Request Demo

Last update 31 Dec 2025

Tamsulosin Hydrochloride

Last update 31 Dec 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryTamsulosin was approved for medical use in the United States in 1997. Specifically it is an α1 adrenergic receptor blocker. Tamsulosin, sold under the brand name Flomax among others, is a medication used to treat symptomatic benign prostatic hyperplasia (BPH) and chronic prostatitis and to help with the passage of kidney stones. The evidence for benefit with a kidney stone is better when the stone is larger. It is taken by mouth. Common side effects include dizziness, headache, sleeplessness, nausea, blurry vision, and sexual problems. Other side effects may include feeling lightheaded with standing and angioedema. Tamsulosin is an alpha blocker and works by relaxing muscles in the prostate.

Drug Type

Small molecule drug

Synonyms

(-)-tamsulosin, (R)-(-)-tamsulosin, (R)-5-(2-((2-(2-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide

+ [36]

Target

α1A-AR

Action

antagonists

Mechanism

α1A-AR antagonists(Alpha-1a adrenergic receptor antagonists)

Therapeutic Areas

Urogenital DiseasesOther DiseasesEndocrinology and Metabolic Disease+ [1]

Active Indication

Lower Urinary Tract SymptomsProstatic HyperplasiaOsteoporosis

Inactive Indication

Acute retention of urineDysuriaErectile Dysfunction+ [6]

Originator Organization

Astellas Pharma, Inc.

Active Organization

Astellas Pharma Europe BV

East China Normal UniversityAstellas Pharma Australia Pty Ltd.

+ [2]

Inactive Organization

Boehringer Ingelheim GmbHYamanouchi Pharmaceutical Co., Ltd.

Astellas Pharma Europe Ltd.

+ [2]

License Organization

Qingdao Baheal Medical, Inc.

Astellas Pharma, Inc.

Drug Highest PhaseApproved

First Approval Date

Japan (02 Jul 1993),

Prostatic Hyperplasia

RegulationPriority Review (China)

Structure/Sequence

Molecular FormulaC20H29ClN2O5S

InChIKeyZZIZZTHXZRDOFM-XFULWGLBSA-N

CAS Registry106463-17-6

370

Clinical Trials associated with Tamsulosin Hydrochloride

NCT07276919

/ Not yet recruitingPhase 4IIT

Perioperative Tamsulosin for Treating Voiding Dysfunction Following Prostate Biopsy: A Multicenter, Randomized, Controlled, Open-Label Study

The goal of this clinical trial is to learn if the drug Tamsulosin Hydrochloride works to treat urination difficulties after a prostate biopsy in men.The main questions it aims to answer are:
* Does Tamsulosin Hydrochloride lower the rate of Acute Urinary Retention (inability to urinate) after a prostate biopsy?
* Does Tamsulosin Hydrochloride improve participants' urination symptoms, quality of life, urine flow rate, and post-void residual urine volume?
Researchers will compare the drug group to a control group (receiving no preventive medication) to see if Tamsulosin Hydrochloride works to prevent urination problems.
Participants will:
* Be randomly assigned to either take Tamsulosin Hydrochloride or receive no preventive medication.
* If in the drug group, take one capsule of Tamsulosin Hydrochloride every night, starting 3 days before the biopsy and continuing until 6 days after the biopsy (10 doses total).
* Undergo a standard prostate biopsy procedure (either through the rectum or perineum).
* Return to the clinic 7 days after the biopsy for a follow-up checkup, which will include questions about their symptoms (IPSS and QoL scores) and tests to measure urine flow and bladder emptying.

Start Date01 Feb 2026

Sponsor / Collaborator

Peking University First Hospital

[+1]

NCT07308002

/ Not yet recruitingPhase 4IIT

Intermittent (Every-Other-Day) vs Daily Tamsulosin for Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia (LUTS/BPH) : A Multicenter, Assessor-Blinded, Randomized Non-Inferiority Trial. Arab Randomized Assessment of BPH Treatment (ARAB Trial)

Background:
Lower urinary tract symptoms (LUTS) are common in aging men, most often due to benign prostatic hyperplasia (BPH), and significantly impair quality of life. α1-adrenoceptor antagonists are first-line therapy, with tamsulosin being the most widely prescribed. However, ejaculatory dysfunction (EjD) is a frequent adverse effect that negatively affects adherence. Optimal dosing strategies that maintain urinary efficacy while reducing EjD are not well defined, and current guidelines provide no recommendations regarding alternate-day dosing.
Patients and Methods:
This multicenter, randomized, open-label, assessor-blinded, parallel-group, non-inferiority trial will enroll men aged ≥50 years with LUTS/BPH and baseline IPSS ≥8. Participants will be randomized 1:1 to receive tamsulosin 0.4 mg once daily or every other day for 24 weeks. The primary endpoint is change in International Prostate Symptom Score (IPSS) from baseline to Week 24. Non-inferiority will be concluded if the upper bound of the two-sided 95% confidence interval (CI) for the between-group difference in mean IPSS change (EOD - Daily) is ≤ +3 points.
The key secondary endpoint is change in Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD) total score from baseline to Week 24, tested for superiority only if IPSS non-inferiority is established. Additional secondary endpoints include maximum urinary flow rate (Qmax), post-void residual volume (PVR), IPSS-Quality of Life score, and ejaculatory adverse-event rates.
Sample Size and Analysis:
Assuming an SD of 6 for IPSS change, a non-inferiority margin of +3, one-sided α of 0.025, and 90% power, approximately 85 evaluable patients per arm are required for the primary endpoint. To ensure adequate power for EjD outcomes and allow for 20% attrition, 144 participants per arm (288 total) will be randomized. Analyses will follow the intention-to-treat principle with per-protocol sensitivity analyses. Primary inference will use ANCOVA or MMRM adjusted for baseline score, age, and study site, with multiple imputation for missing data.
Expected Outcomes:
This trial will provide the first adequately powered multicenter evidence on whether every-other-day tamsulosin preserves non-inferior LUTS control while improving ejaculatory outcomes, potentially supporting a simple and cost-effective strategy to enhance tolerability and adherence in men with LUTS/BPH.

Start Date01 Jan 2026

Sponsor / Collaborator

Mansoura University

NCT07310797

/ Not yet recruitingPhase 4IIT

A Randomized Controlled Trial Comparing Mirabegron and Tamsulosin for Ureteral Stone Expulsion and Clinical Symptom Improvement

This randomized controlled trial compares the efficacy and safety of four treatment strategies for ureteral stone expulsion: Mirabegron alone, Tamsulosin alone, a combination of both, and standard conservative care. Participants diagnosed with ureteral stones will be randomly assigned to one of these four groups. The primary objective is to evaluate the stone expulsion rate within 4 weeks. The study also assesses time to expulsion, pain intensity, analgesic use, and potential side effects.

Start Date01 Jan 2026

Sponsor / Collaborator-

100 Clinical Results associated with Tamsulosin Hydrochloride

100 Translational Medicine associated with Tamsulosin Hydrochloride

100 Patents (Medical) associated with Tamsulosin Hydrochloride

2,716

Literatures (Medical) associated with Tamsulosin Hydrochloride

01 Nov 2025·Actas urologicas espanolas

Does preoperative alpha-blocker use affect the results of flexible ureterorenoscopy?

Article

Author: Sanci, A ; Gogus, C ; Akinci, A ; Babayigit, M

OBJECTIVE:

To evaluate the effect of alpha-blocker therapy during flexible ureterorenoscopy (F-URS) on the treatment of upper urinary tract stones.

METHODS:

A retrospective analysis was conducted on 476 patients who underwent F-URS at the Department of Urology between January 2010 and January 2017. Data collected included alpha-blocker use, stone size, stone location, patient age and gender, success or failure of ureteral access sheath (UAS) placement, ability to reach the stone during the procedure, postoperative stone-free status, and complication rates. Patients were divided into two groups: alpha-blocker users (n = 90, 18.9%) and non-users (n = 386, 81.1%).

RESULTS:

No significant differences were observed in gender distribution (P = 0.86) or stone size (P = 0.21) between the two groups. Alpha-blocker users had a lower complication rate (P = 0.022), a higher rate of successful stone access during the procedure (P = 0.007), and a higher postoperative stone-free rate (P = 0.01) compared to non-users. Among alpha-blocker users, tamsulosin and silodosin were associated with higher stone clearance rates (P = 0.046 and P = 0.037, respectively).

CONCLUSIONS:

Alpha-blocker therapy during F-URS for upper urinary tract stones is associated with improved outcomes, including higher stone access rates, reduced complications, and increased stone-free rates. These findings suggest that alpha-blockers, particularly tamsulosin and silodosin, may enhance the efficacy and safety of F-URS.

03 Oct 2025·Cardiovascular & hematological agents in medicinal chemistry

Novel Compounds in Targeting the α1-adrenoceptor for Antihypertensive Therapy

Article

Author: Saraf, Swarnlata ; Dewangan, Dhansay ; Tirkey, Rakesh ; Minj, Pankaj ; Sahu, Sunil

Abstract::

Hypertension, a prevalent cardiovascular condition, increases the risk of strokes and myocardial infarctions by inducing elevated blood pressure. Its prevalence has risen, particularly in low- and middle-income nations. The incidence of hypertension in adults is higher in low- and middle-income countries compared to high-income nations. One significant class of antihypertensive drugs is α1-adrenoceptor antagonists, which inhibit α1-adrenergic receptors and promote vasodilation. Terazosin, doxazosin, tamsulosin, and alfuzosin are examples of α1-adrenoceptor antagonists that have antihypertensive properties; however, they are linked to considerable side effects, including headaches, dizziness, reproductive problems, and postural hypotension. In the last several years, a number of novel α1-adrenergic antagonists have been synthesised by modifications of various pharmacophores such as Isochroman-4-one, Quinazolines, Piperazine, and Quinazoline-triazole, etc. The present review highlights recently synthesized α1-adrenoceptor antagonists for the management of hypertension, and emphasizes their structure-activity relationship and subtype selectivity.

01 Oct 2025·INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS

Bioequivalence of tamsulosin 0.4 mg film-coated sustained-release tablet formulations in healthy subjects under fasting conditions

Article

Author: Yunaidi, Danang Agung ; Aziswan, Syifa Anugriani ; Nindyatami, Clarasintha ; Tjandrawinata, Raymond R. ; Susanto, Liana W. ; Kurniawan, Yantirta Indra ; Saputro, Ismail Dwi ; Ginanjar, Vicky Achmad

This open-label, randomized, single-dose, 4-period, 2-sequence, fully replicated study was conducted to evaluate the bioequivalence of tamsulosin 0.4 mg sustained-release film-coated tablet manufactured by PT Dexa Medica, Indonesia, and Harnal OCAS 0.4 mg prolonged-release tablet manufactured by Astellas Pharma Europe B.V., the Netherlands, imported by PT Combiphar, Indonesia, under fasting conditions in 28 healthy adult Indonesian males. Subjects were randomly assigned to receive the test formulation (1 single tablet of 0.4 mg) or the reference formulation (1 single tablet of 0.4 mg) orally in each of the 4 study periods, according to the full replicate design. Therefore, over the 4 complete periods, each subject received 2 administrations of the test formulation and 2 administrations of the reference formulation, with each administration separated by a 7-day washout period. The plasma concentration of tamsulosin from the blood samples was analyzed using validated ultra-performance liquid chromatography with tandem mass spectroscopy detection (UPLC-MS/MS), and pharmacokinetic parameters (AUC_0-t, AUC_0-∞, C_max, t_max, and T_1/2) were calculated. The 90% confidence interval (CI) for the test/reference geometric mean ratio (GMR) of the AUC_0-t was 80.2 - 98.4%, and for AUC_0-∞ it was 80.5 - 120.1%. The 90% CI GMR of C_max was 89.3 - 107.7%. All parameters were within the 90% CI GMR acceptance criteria of 80.0 - 125.0%. The T_1/2 and t_max of the 2 test drugs and the 2 reference drugs were not statistically different. There was no adverse effect observed during the study. Based on the study results, it was concluded that both tamsulosin formulations were bioequivalent and well tolerated.

News (Medical) associated with Tamsulosin Hydrochloride

15 May 2025

·www.globenewswire.com

Teleflex Showcases New Clinical Data Presented at the 2025 American Urological Association (AUA) Annual Meeting

Two Head-to-Head Randomized Trials Highlight Superior Early Patient Experience with the UroLift™ System for BPH1-2 First-Ever Analysis Utilizing the American Urological Association Quality Registry (AQUA) to Assess BPH Treatment Modalities Shows Strongest Symptom Improvement Score Shift with UroLift™ System at Three Months.3 First Study to Confirm Safety of Stabilized Hyaluronic Acid (sHA) Rectal Spacer in Cases with Rectal Wall Infiltration (RWI).4 WAYNE, Pa., May 15, 2025 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a global leader in medical technologies, today announced the presentation of compelling new clinical data at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, held April 26–29. Data from two randomized controlled trials (RCTs) reinforce the UroLift™ System’s advantages compared with Rezūm and tamsulosin, particularly in terms of early patient satisfaction, rapid symptom relief, and sexual function outcomes.1-2 The UroLift™ System, also referred to as Prostatic Urethral Lift (PUL), is the chosen leader in minimally invasive procedures for benign prostatic hyperplasia (BPH) in the U.S.5 “These studies underscore our commitment to evidence-based innovation. The UroLift™ System continues to stand out as a patient-centered therapy offering meaningful improvements in symptoms and quality of life,” said Claus Roehrborn, MD,* professor of urology at UT Southwestern Medical Center and primary investigator on the studies. “With more than 14 years of BPH research behind us, including ongoing head-to-head comparisons, we’re giving clinicians and patients the critical data to support evidence-based shared decisions.”The following research presentations outlined the key findings from the studies: Results from the CLEAR RCT Suggest Factors Corresponding to Early Patient Satisfaction Are Better Following UroLift PUL vs. Rezum WVTT1† Men treated with the UroLift™ System were significantly more satisfied with their results at two weeks and at one month after treatment.1Those who received the UroLift™ System procedure also had shorter catheterization times, better symptom relief, and better sexual function outcomes during the early recovery period compared to Rezūm™ patients.1 UroLift™ PUL Demonstrates Significantly Better Efficacy and Patient Experience Outcomes vs. Tamsulosin: Results from the IMPACT RCT2† At three months, men who were treated with the UroLift™ System showed significantly better symptom improvement compared to those who took medication.2UroLift™ System patients reported better sexual function outcomes and overall experience.‡ In fact, 70% of men randomized to the medication treatment arm eventually chose to crossover to the UroLift™ System.2 Using the American Urological Association Quality Registry (AQUA) BPH Dataset to Assess Early Symptom Improvement after Treatment3 Real-world data from the AQUA BPH database corroborate evidence that BPH drugs provide modest or no improvement and that PUL provides rapid symptom score improvement at three months.3 Safety of Stabilized Hyaluronic Acid (sHA) as a Rectal Spacer: Low Risk of Rectal Wall Infiltration and Reversibility4 This study presents the first evidence for the safety of sHA rectal spacer in cases of RWI, demonstrating sHA spacers are safe, effective, and allow for individualized spacing with low risk of severe complications, such as ulcers or fistulas.4 “These findings reaffirm the safety profile of stabilized hyaluronic acid as a rectal spacer and highlight its reversibility as a distinct clinical advantage,” said Michelle Svatos, director of Barrigel™ rectal spacer product development and research. “With a low incidence of rectal wall infiltration and no severe complications observed, this study strengthens our confidence in sHA as a safe and customizable option for protecting patients during prostate cancer treatment." For more information about the UroLift System, visit www.UroLift.com, and for more information about Barrigel Rectal Spacer, visit www.Barrigel.com. About the UroLift™ SystemThe UroLift™ System is a minimally invasive treatment for lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). It is indicated for the treatment of symptoms of an enlarged prostate up to 100cc in men 45 years or older (50 years outside U.S.). The UroLift™ System permanent implants, which can be delivered during an outpatient procedure,6 relieve prostate obstruction without heating, cutting, destruction of, or removing prostate tissue. The UroLift™ System can be used to treat a broad spectrum of anatomies, including obstructive median lobe.7 It is the only leading BPH procedure shown to not cause new onset, sustained erectile or ejaculatory dysfunction.**8-9 A study conducted over 5 years showed a low retreatment rate of about 2-3% per year, or a total of 13.6% over the course of the study, demonstrating UroLift™ System durability.10 Most common side effects are temporary and can include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence.11 Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Individual results may vary. The prostatic urethral lift procedure (using the UroLift™ System) is recommended for the treatment of BPH in both the 2021 American Urological Association and 2022 European Association of Urology clinical guidelines. 500,000 men have been treated with the UroLift™ System in select markets worldwide.12 Learn more at www.UroLift.com. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. About Barrigel™ Rectal SpacerBarrigel™ rectal spacer is the first and only hyaluronic acid rectal spacer that separates the prostate from the rectum to protect the rectum during radiation therapy treatment for prostate cancer.13 Barrigel™ rectal spacer is made from Non-Animal Stabilized Hyaluronic Acid (NASHA).14 Hyaluronic acid is a substance naturally present in the human body and is highly biocompatible and fully absorbable. NASHA has a proven history of safety and efficacy in a wide variety of medical applications in men, women and children worldwide.15-16 Barrigel™ rectal spacer has been proven to significantly reduce unwanted side effects from prostate cancer radiation therapy13 and is cleared for rectal spacing in the United States, Australia, and Europe.17 Barrigel™ rectal spacer is indicated for prostate cancer patients with T1-T3b disease. For more information about Barrigel™ rectal spacer, please visit https://barrigel.com/hcp/barrigel-control-matters. Barrigel™ Rectal Spacer Important Safety InformationBarrigel™ rectal spacer is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and, in creating this space, it is the intent of Barrigel™ rectal spacer to reduce the radiation dose delivered to the anterior rectum. Barrigel™ rectal spacer is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is intended to be absorbed by the patient’s body over time. Barrigel™ rectal spacer should only be administered by qualified and properly trained physicians with experience in ultrasound guidance and injection techniques in the urogenital/pelvic area. As with any medical treatment, there are some risks involved with the use of Barrigel™ rectal spacer. Potential complications associated with the use of Barrigel™ rectal spacer include, but are not limited to: pain associated with Barrigel™ rectal spacer injection; needle penetration of the bladder, prostate, rectal wall, rectum, or urethra; injection of Barrigel™ rectal spacer into the bladder, prostate, rectal wall, rectum, urethra, or intravascularly; local inflammatory reactions; infection; urinary retention; rectal mucosal damage, ulcers, necrosis; bleeding; constipation; and rectal urgency. More information on indications, contraindications, warnings and instructions for use can be found in the Instructions For Use at www.barrigel.com. Individual results may vary. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. About Teleflex Incorporated As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose driven innovation, and world-class products can shape the future direction of healthcare. Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com. Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management’s current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K. Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. All other trademarks are the property of their respective owners. © 2025 Teleflex Incorporated. All rights reserved. References *Paid consultants of Teleflex.**No instances of new, sustained erectile or ejaculatory dysfunction in the L.I.F.T. pivotal study †Studies sponsored by Teleflex.‡Sexual function is a combination of MSHQ EjD, MSHQ Bother, and IIEF scores. For overall patient experience, this includes a combination of results from tools to assess Symptoms, QoL, Patient Perception, Goal Achievement, and Sleep. Chughtai et al, AUA 2025. Results from the CLEAR Randomized Controlled Trial (RCT) Suggest Factors Corresponding to Early Patient Satisfaction Are Better Following UroLift PUL Versus Rezum WVTT. †Roehrborn et al, AUA 2025. UroLift™ PUL Demonstrates Significantly Better Efficacy and Patient Experience Outcomes vs. Tamsulosin: Results from the IMPACT RCT.†Roehrborn. Using the American Urological Association Quality Registry (AQUA) BPH Dataset to Assess Early Symptom Improvement after Treatment. Poster presented at AUA; April 26, 2025. Las Vegas, NV.Chao et al, AUA 2025. Safety of Stabilized Hyaluronic Acid (sHA) as a Rectal Spacer: Low Risk of Rectal Wall Infiltration and Reversibility.U.S. 2023 estimates based on US Market Model 2023-25 (3-14-23 FINAL), which is in part based on Symphony Health PatientSource® 2018-22, as is and with no representations/warranties, including accuracy or completeness.Shore, Can J Urol 2014Rukstalis, Prostate Cancer and Prostatic Dis 2018AUA BPH Guidelines 2003, 2020McVary, Urology 2019Roehrborn, Can J Urol 2017Roehrborn, J Urol 2013Management estimate based on product sales as of June 2024. Data on file Teleflex Interventional Urology.Mariados NF, Orio PF III, King MT et al. JAMA Oncol (2023).Barrigel Injectable Gel Instructions for Use (2022).Svatos M, Chell E, Low DA, et al. Symmetry, separation, and stability: Physical properties for effective dosimetric space with a stabilized hyaluronic acid spacer. Med Phys. 2024; 1-15. https://doi-org.sutd.idm.oclc.org/10.1002/mp.17292†Restylane® celebrates 25 years of natural-looking results with its signature line of hyaluronic acid fillers. 2021. Available at: https://www.prnewswire.com/news-releases/restylane-celebrates-25-years-of-natural-looking-results-with-its-signature-line-of-hyaluronic-acid-fillers-301388779.html. Accessed Sept 30, 2021.Data on file Teleflex. 2025. MAC03086-01 Rev A Contacts:TeleflexLawrence KeuschVice President, Investor Relations and Strategy Developmentinvestor.relations@teleflex.com610-948-2836 Media Contact:Glenn SilverPartner National Media Relations Specialistglenn.silver@finnpartners.com646-871-8485

Clinical ResultRadiation TherapyClinical Study

15 May 2025

·www.einpresswire.com

Teleflex Showcases New Clinical Data Presented at the 2025 American Urological Association (AUA) Annual Meeting

Two Head-to-Head Randomized Trials Highlight Superior Early Patient Experience with the UroLift™ System for BPH 1 -2 First-Ever Analysis Utilizing the American Urological Association Quality Registry (AQUA) to Assess BPH Treatment Modalities Shows Strongest Symptom Improvement Score Shift with UroLift™ System at Three Months. 3 First Study to Confirm Safety of Stabilized Hyaluronic Acid (sHA) Rectal Spacer in Cases with Rectal Wall Infiltration (RWI). 4 WAYNE, Pa., May 15, 2025 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a global leader in medical technologies, today announced the presentation of compelling new clinical data at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, held April 26–29. Data from two randomized controlled trials (RCTs) reinforce the UroLift™ System’s advantages compared with Rezūm and tamsulosin, particularly in terms of early patient satisfaction, rapid symptom relief, and sexual function outcomes. 1-2 The UroLift™ System, also referred to as Prostatic Urethral Lift (PUL), is the chosen leader in minimally invasive procedures for benign prostatic hyperplasia (BPH) in the U.S. 5 “These studies underscore our commitment to evidence-based innovation. The UroLift™ System continues to stand out as a patient-centered therapy offering meaningful improvements in symptoms and quality of life,” said Claus Roehrborn, MD,* professor of urology at UT Southwestern Medical Center and primary investigator on the studies. “With more than 14 years of BPH research behind us, including ongoing head-to-head comparisons, we’re giving clinicians and patients the critical data to support evidence-based shared decisions.” The following research presentations outlined the key findings from the studies: Results from the CLEAR RCT Suggest Factors Corresponding to Early Patient Satisfaction Are Better Following UroLift PUL vs. Rezum WVTT 1 † Men treated with the UroLift™ System were significantly more satisfied with their results at two weeks and at one month after treatment. 1 Those who received the UroLift™ System procedure also had shorter catheterization times, better symptom relief, and better sexual function outcomes during the early recovery period compared to Rezūm™ patients. 1 UroLift™ PUL Demonstrates Significantly Better Efficacy and Patient Experience Outcomes vs. Tamsulosin: Results from the IMPACT RCT 2 † At three months, men who were treated with the UroLift™ System showed significantly better symptom improvement compared to those who took medication. 2 UroLift™ System patients reported better sexual function outcomes and overall experience.‡ In fact, 70% of men randomized to the medication treatment arm eventually chose to crossover to the UroLift™ System. 2 Using the American Urological Association Quality Registry (AQUA) BPH Dataset to Assess Early Symptom Improvement after Treatment 3 Real-world data from the AQUA BPH database corroborate evidence that BPH drugs provide modest or no improvement and that PUL provides rapid symptom score improvement at three months. 3 Safety of Stabilized Hyaluronic Acid (sHA) as a Rectal Spacer: Low Risk of Rectal Wall Infiltration and Reversibility 4 This study presents the first evidence for the safety of sHA rectal spacer in cases of RWI, demonstrating sHA spacers are safe, effective, and allow for individualized spacing with low risk of severe complications, such as ulcers or fistulas. 4 “These findings reaffirm the safety profile of stabilized hyaluronic acid as a rectal spacer and highlight its reversibility as a distinct clinical advantage,” said Michelle Svatos, director of Barrigel™ rectal spacer product development and research. “With a low incidence of rectal wall infiltration and no severe complications observed, this study strengthens our confidence in sHA as a safe and customizable option for protecting patients during prostate cancer treatment." For more information about the UroLift System, visit www.UroLift.com , and for more information about Barrigel Rectal Spacer, visit www.Barrigel.com . About the UroLift™ System The UroLift™ System is a minimally invasive treatment for lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). It is indicated for the treatment of symptoms of an enlarged prostate up to 100cc in men 45 years or older (50 years outside U.S.). The UroLift™ System permanent implants, which can be delivered during an outpatient procedure, 6 relieve prostate obstruction without heating, cutting, destruction of, or removing prostate tissue. The UroLift™ System can be used to treat a broad spectrum of anatomies, including obstructive median lobe. 7 It is the only leading BPH procedure shown to not cause new onset, sustained erectile or ejaculatory dysfunction.** 8-9 A study conducted over 5 years showed a low retreatment rate of about 2-3% per year, or a total of 13.6% over the course of the study, demonstrating UroLift™ System durability. 10 Most common side effects are temporary and can include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence. 1 1 Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Individual results may vary. The prostatic urethral lift procedure (using the UroLift™ System) is recommended for the treatment of BPH in both the 2021 American Urological Association and 2022 European Association of Urology clinical guidelines. 500,000 men have been treated with the UroLift™ System in select markets worldwide. 1 2 Learn more at www.UroLift.com . Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. About Barrigel™ Rectal Spacer Barrigel ™ rectal spacer is the first and only hyaluronic acid rectal spacer that separates the prostate from the rectum to protect the rectum during radiation therapy treatment for prostate cancer. 1 3 Barrigel™ rectal spacer is made from Non-Animal Stabilized Hyaluronic Acid (NASHA). 1 4 Hyaluronic acid is a substance naturally present in the human body and is highly biocompatible and fully absorbable. NASHA has a proven history of safety and efficacy in a wide variety of medical applications in men, women and children worldwide. 15-16 Barrigel ™ rectal spacer has been proven to significantly reduce unwanted side effects from prostate cancer radiation therapy 1 3 and is cleared for rectal spacing in the United States, Australia, and Europe. 1 7 Barrigel ™ rectal spacer is indicated for prostate cancer patients with T1-T3b disease. For more information about Barrigel ™ rectal spacer, please visit https://barrigel.com/hcp/barrigel-control-matters . Barrigel™ Rectal Spacer Important Safety Information Barrigel™ rectal spacer is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and, in creating this space, it is the intent of Barrigel™ rectal spacer to reduce the radiation dose delivered to the anterior rectum. Barrigel™ rectal spacer is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is intended to be absorbed by the patient’s body over time. Barrigel™ rectal spacer should only be administered by qualified and properly trained physicians with experience in ultrasound guidance and injection techniques in the urogenital/pelvic area. As with any medical treatment, there are some risks involved with the use of Barrigel™ rectal spacer. Potential complications associated with the use of Barrigel™ rectal spacer include, but are not limited to: pain associated with Barrigel™ rectal spacer injection; needle penetration of the bladder, prostate, rectal wall, rectum, or urethra; injection of Barrigel™ rectal spacer into the bladder, prostate, rectal wall, rectum, urethra, or intravascularly; local inflammatory reactions; infection; urinary retention; rectal mucosal damage, ulcers, necrosis; bleeding; constipation; and rectal urgency. More information on indications, contraindications, warnings and instructions for use can be found in the Instructions For Use at www.barrigel.com . Individual results may vary. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. About Teleflex Incorporated As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose driven innovation, and world-class products can shape the future direction of healthcare. Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com . Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management’s current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K. Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. All other trademarks are the property of their respective owners. © 2025 Teleflex Incorporated. All rights reserved. References *Paid consultants of Teleflex. **No instances of new, sustained erectile or ejaculatory dysfunction in the L.I.F.T. pivotal study †Studies sponsored by Teleflex. ‡Sexual function is a combination of MSHQ EjD, MSHQ Bother, and IIEF scores. For overall patient experience, this includes a combination of results from tools to assess Symptoms, QoL, Patient Perception, Goal Achievement, and Sleep. Chughtai et al, AUA 2025. Results from the CLEAR Randomized Controlled Trial (RCT) Suggest Factors Corresponding to Early Patient Satisfaction Are Better Following UroLift PUL Versus Rezum WVTT. † Roehrborn et al, AUA 2025. UroLift™ PUL Demonstrates Significantly Better Efficacy and Patient Experience Outcomes vs. Tamsulosin: Results from the IMPACT RCT.† Roehrborn. Using the American Urological Association Quality Registry (AQUA) BPH Dataset to Assess Early Symptom Improvement after Treatment . Poster presented at AUA; April 26, 2025. Las Vegas, NV. Chao et al, AUA 2025. Safety of Stabilized Hyaluronic Acid (sHA) as a Rectal Spacer: Low Risk of Rectal Wall Infiltration and Reversibility. U.S. 2023 estimates based on US Market Model 2023-25 (3-14-23 FINAL), which is in part based on Symphony Health PatientSource® 2018-22, as is and with no representations/warranties, including accuracy or completeness. Shore, Can J Urol 2014 Rukstalis, Prostate Cancer and Prostatic Dis 2018 AUA BPH Guidelines 2003, 2020 McVary, Urology 2019 Roehrborn, Can J Urol 2017 Roehrborn, J Urol 2013 Management estimate based on product sales as of June 2024. Data on file Teleflex Interventional Urology. Mariados NF, Orio PF III, King MT et al. JAMA Oncol (2023). Barrigel Injectable Gel Instructions for Use (2022). Svatos M, Chell E, Low DA, et al. Symmetry, separation, and stability: Physical properties for effective dosimetric space with a stabilized hyaluronic acid spacer. Med Phys . 2024; 1-15. https://doi-org.sutd.idm.oclc.org/10.1002/mp.17292 † Restylane ® celebrates 25 years of natural-looking results with its signature line of hyaluronic acid fillers. 2021. Available at: https://www.prnewswire.com/news-releases/restylane-celebrates-25-years-of-natural-looking-results-with-its-signature-line-of-hyaluronic-acid-fillers-301388779.html . Accessed Sept 30, 2021. Data on file Teleflex. 2025. MAC03086-01 Rev A Contacts: Teleflex Lawrence Keusch Vice President, Investor Relations and Strategy Development investor.relations@teleflex.com 610-948-2836 Media Contact: Glenn Silver Partner National Media Relations Specialist glenn.silver@finnpartners.com 646-871-8485 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Clinical ResultRadiation TherapyClinical Study

02 Apr 2025

·www.prnewswire.com

Hanmi Pharmaceutical's 'Gugutams' to be Launched in Mexico as 'Aditams', Marking the Start of Full-Scale Latin America Expansion

Hanmi Pharm Begins Local Sales of Urological Product 'Aditams' in Mexico with Partner 'Laboratorios Silanes' Launch completed in February, Hanmi Pharm's Third Product to Enter Latin America Aditams, The First Urological Combination Drug for OPG and ED Exported to Mexico SEOUL, South Korea, April 2, 2025 /PRNewswire/ -- Hanmi Pharmaceutical's combination therapy for Obstructive Prostatic Growth (OPG) caused by Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED), Gugutams, is entering the Mexican market under the local brand name "Aditams." Continue Reading Aditams Hanmi Pharmaceutical announced that it has completed the launch of Aditams in Mexico under the export agreement signed in October 2020 with the Mexican pharmaceutical company 'Laboratorios Silanes'. Under the agreement, Hanmi Pharmaceutical plans to export Gugutams to the Mexican market for a period of seven years, starting in February 2025. Gugutams, developed by Hanmi Pharmaceutical, is the world's first urological combination therapy combining two active ingredients: tamsulosin, a treatment for Obstructive Prostatic Growth (OPG), and tadalafil, a treatment for erectile dysfunction (ED). It is also noteworthy as the first prescription drug in Korea to apply Poly-Cap technology, which integrates multiple active ingredients into a single capsule. Laboratorios Silanes, a leading pharmaceutical company in Mexico founded in 1943, is committed to providing innovative healthcare solutions and driving rapid growth in the industry. It has established itself as a key player in the Latin American pharmaceutical market through its robust distribution network and strategic collaborations with global partners. Silanes previously collaborated with Hanmi Pharmaceutical in 2023 to successfully introduce the hypertension and dyslipidemia combination treatment 'Amosartan Q', under the local brand 'Lodarta' and in 2024 to introduce the combination hypertension treatment 'Amosartan Plus' under the local brand 'Bicartial-CTD'. Following these products, Gugutams, under the local brand 'Aditams', becomes Hanmi Pharmaceutical's third product in the Latin American region. Aditams, as the first urological combination therapy to enter the Mexican market, is expected to offer a new treatment option for patients suffering from both Obstructive Prostatic Growth (OPG) and erectile dysfunction (ED). By managing both conditions with a single medication, it significantly enhances patient convenience and maximizes therapeutic efficacy. Hanmi continues to focus on expanding its partnerships in emerging markets such as the Middle East and Latin America, in addition to its established presence in developed markets like North America and Japan. The company aims to leverage strategic partners like Laboratorios Silanes as key footholds to broaden its product portfolio and regional reach. Park Jae-hyun, CEO of Hanmi Pharmaceutical, stated, "As the first urological combination therapy to enter the Mexican market, Gugutams is expected to present a new treatment paradigm for local patients." He added, "Through this collaboration with Laboratorios Silanes, we aim to solidify Hanmi Pharmaceutical's presence in the Latin American market and leverage this as a foundation to further strengthen our competitiveness in the global pharmaceutical industry." Official Websites: About Hanmi Pharmaceutical: Hanmi Pharmaceutical is an R&D-focused pharmaceutical company committed to developing globally innovative therapies in areas of high unmet medical needs such as obesity/metabolism, oncology, and rare diseases. Hanmi leverages proprietary platform technologies, including long-acting biologics and bispecific antibodies, to address unmet medical needs. The company emphasizes open innovation and has established numerous global partnerships to advance its research and development efforts. SOURCE Hanmi Pharmaceutical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalLicense out/inBiosimilar

100 Deals associated with Tamsulosin Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01024	Tamsulosin Hydrochloride	G04CA02	DB00706

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Lower Urinary Tract Symptoms	Belgium	Astellas Pharma Europe BV	01 Mar 2005
Lower Urinary Tract Symptoms	Luxembourg	Astellas Pharma Europe BV	01 Mar 2005
Hypertension	United States	Sanofi-Aventis U.S. LLC	15 Apr 1997
Prostatic Hyperplasia	Japan	Astellas Pharma, Inc.	02 Jul 1993

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Urological Manifestations	Phase 3	United States	Boehringer Ingelheim GmbH	23 Sep 2015
Urinary Bladder, Neurogenic	Phase 3	United States	Boehringer Ingelheim GmbH	01 Jan 2008
Urinary Bladder, Neurogenic	Phase 3	Belgium	Boehringer Ingelheim GmbH	01 Jan 2008
Urinary Bladder, Neurogenic	Phase 3	Brazil	Boehringer Ingelheim GmbH	01 Jan 2008
Urinary Bladder, Neurogenic	Phase 3	Germany	Boehringer Ingelheim GmbH	01 Jan 2008
Urinary Bladder, Neurogenic	Phase 3	India	Boehringer Ingelheim GmbH	01 Jan 2008
Urinary Bladder, Neurogenic	Phase 3	Italy	Boehringer Ingelheim GmbH	01 Jan 2008
Urinary Bladder, Neurogenic	Phase 3	Mexico	Boehringer Ingelheim GmbH	01 Jan 2008
Urinary Bladder, Neurogenic	Phase 3	Philippines	Boehringer Ingelheim GmbH	01 Jan 2008
Urinary Bladder, Neurogenic	Phase 3	Russia	Boehringer Ingelheim GmbH	01 Jan 2008

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05890235 (Pubmed \| Front Pharmacol)	Phase 4	Chronic pelvic pain syndrome	323	Ningmitai capsule (NMT) 1.52 g thrice daily	gcoucllrph(aeqokdlntt) = mcltkevotm bchrxyciry (rvlohlerff )	Positive	03 Dec 2025
				Ningmitai capsule + tamsulosin	gcoucllrph(aeqokdlntt) = ynrptgriou bchrxyciry (rvlohlerff )
NCT05753670 (CTgov)	Phase 3	Urinary Retention	179	Tamsulosin (Tamsulosin)	gyebpoysfo = nmervlgvfc koficylmnl (vmskdnnsgk, opcinnygtw - botyjtdhcj) View more	-	28 Oct 2025
				Placebo (Placebo)	gyebpoysfo = waixkyskoh koficylmnl (vmskdnnsgk, avxhmpgliq - nxxsdzvskb) View more
NCT05415748 (PERSONAL, CTgov)	Phase 4	Prostatic Hyperplasia \| Lower Urinary Tract Symptoms	31	Tamsulosin+Placebo (Placebo Then Tamsulosin, Placebo Then Tamsulosin)	pmrtaygfyp(flxobkkpsw) = ecejazopjs xxuqalhvuy (diczlrwlpi, 9.5) View more	-	22 Aug 2025
				Tamsulosin+Placebo (Placebo Then Tamsulosin, Tamsulosin Then Placebo)	pmrtaygfyp(flxobkkpsw) = kcliqxtolu xxuqalhvuy (diczlrwlpi, 8.0) View more
NCT03750656 (HyTa Stent, CTgov)	Phase 4	Lower Urinary Tract Symptoms	5	Hyoscyamine (Hyoscyamine)	fxtpsqvkdt(youpvhlobp) = iqbyqrdtyf egozkkslrn (tienyidxuk, kfbekvivoh - qqlryedoay) View more	-	03 Dec 2024
				Tamsulosin (Tamsulosin)	fxtpsqvkdt(youpvhlobp) = nxqakirvbu egozkkslrn (tienyidxuk, cmswxshzkk - tpgkvuvfkn) View more
NCT04859660 (A Randomized Controlled Trial, Pubmed \| Obstet Gynecol)	Phase 2	Urinary Retention	150	Tamsulosin 0.4 mg	uefbvdfqvt(wknvhkzmjh) = vaspkzcjyp hoseowjfmj (cryzonxjeh )	Negative	01 Dec 2024
				Placebo	uefbvdfqvt(wknvhkzmjh) = xdthyakewe hoseowjfmj (cryzonxjeh )
NCT01568918 (CTgov)	Phase 3	Urinary Retention	90	Tamsulosin hydrochloride (Tamsulosin)	gijpsfbcol = isjnmmsdnv oitblszzzw (gkymrquqes, gaixzchgam - jcbmwmnmas) View more	-	30 May 2024
				Placebo (Placebo)	gijpsfbcol = utzwphepsj oitblszzzw (gkymrquqes, dazopbzjpa - bqabjruzle) View more
NCT04859660 (A Randomized Controlled Trial, CTgov)	Phase 2	Urinary Retention	161	Tamsulosin (Tamsulosin- Intervention Group)	sfnxuhjxqe(pwzfimhmmj) = irjmgqzqik gzwykmejna (anbbttfmxw, tpyboikjcb - cdizmmsyjf) View more	-	29 Feb 2024
				Placebo (Placebo Group)	sfnxuhjxqe(pwzfimhmmj) = dydoheyyst gzwykmejna (anbbttfmxw, tchdjhvunw - amolljzgei) View more
NCT04682366 (CTgov)	Phase 4	Urinary Retention	4	Tamsulosin (Tamsulosin)	oualclwujx = ngrmbwpdyg wvyihibfil (kcrdmabsmg, syvuyhvsxf - ehpnnsjidt) View more	-	31 Jan 2024
				Placebo (Placebo)	oualclwujx = kxrdnamspe wvyihibfil (kcrdmabsmg, mvedlfalpi - rcuaqkbnel) View more
AUA2023	Not Applicable	Prostatic Hyperplasia	160	Tamsulosin	dihrqudonk(dwavqdtbbf) = mieybtgrqc cjnvltgqxn (zsdqfoaqnz )	-	01 Apr 2023
				Tadalafil 5 mg	dihrqudonk(dwavqdtbbf) = jxerkuajah cjnvltgqxn (zsdqfoaqnz )
NCT04819828 (Pubmed \| Int J Clin Pract)	Phase 4	Kidney Calculi Adjuvant	60	Tamsulosin	dyyzvexzzo(lolfzxlvgf) = ixhhtyyyxh rbvzaabgvj (svianpsxyc )	Negative	01 Jan 2022
				tamsulosin (Control)	dyyzvexzzo(lolfzxlvgf) = caeonypgkj rbvzaabgvj (svianpsxyc )

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Tamsulosin Hydrochloride

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation