This multicenter, prospective, observational, non-interventional study investigates patients with intracranial hemorrhage under effective anticoagulation with dabigatran or vitamin-K antagonist (VKA). Routine data will be collected during hospitalization. Patients aged 18 years or older under effective therapy with dabigatran and symptomatic intracranial bleeding confirmed by cerebral imaging and treated with idarucizumab will be compared to patients under effective treatment with VKA at the time of onset of the intracranial bleeding. Ninety-five dabigatran patients who provided written informed consent for data transmission will be included. As control group retrospective and anonymized data of 285 VKA patients patients under VKA treatment and admitted to RIC-ICH study centers will be used. For each patient receiving idarucizumab, three patients with intracranial hemorrhage under effective treatment with VKA, will be included (retrospective) in the study. In addition, data of VKA patients will be transferred from the RASUNOA-PRIME and the "Erlanger Hirnblutungs-Register".

Start Date19 Sep 2019

Sponsor / Collaborator

University Hospital Of Essen

NCT02798107

/ WithdrawnNot Applicable

Safety of Potential Paediatric Patients Treated With Idarucizumab: a Non-internventional Chart Review Study

Idarucizumab is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran with very high affinity. Idarucizumab potently and specifically binds to dabigatran and its metabolites and neutralises its anticoagulant effect. A clinical development program is ongoing to support marketing authorisation submissions for idarucizumab indicated in patients treated with dabigatran who require emergency surgery/urgent procedures or who have a life-threatening or uncontrolledbleeding when rapid reversal of the anticoagulant effects of dabigatran is required.

Start Date20 May 2019

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT03359889

/ CompletedNot Applicable

Post Marketing Surveillance Program of Praxbind Use in India.

This program will be initiated after the commercial availability of PraxbindTM in India. It will include patients administered with PraxbindTM into the surveillance program after commercial availability in 2 years at selected centres approved by the regulatory authority.

Start Date26 Dec 2018

Sponsor / Collaborator

Boehringer Ingelheim GmbH

100 Clinical Results associated with Idarucizumab

100 Translational Medicine associated with Idarucizumab

100 Patents (Medical) associated with Idarucizumab

580

Literatures (Medical) associated with Idarucizumab

01 Oct 2025·ANESTHESIOLOGY

Intravenous Dabigatran for Anticoagulation during Cardiopulmonary Bypass in a Sheep Model

Article

Author: Stefanos, Tatsiana ; Angona, Ronald E. ; Nadtochiy, Sergiy M. ; Swartz, Michael F. ; Gu, Yang ; LeMoine, Dana ; Jones, Karen ; Major, Lauren A. ; Anderson, Brian J. ; Feng, Changyong ; Darrow, Nathan ; Eaton, Michael P.

Background::

Heparin is the standard anticoagulant used during cardiopulmonary bypass (CPB). However, there are problems with heparin, including immunogenicity and variability of effect, that make a search for an alternative desirable. Dabigatran anticoagulation has been reported to provide adequate conditions for CPB in a rabbit model. This study used a sheep model of CPB to assess the efficacy of dabigatran and its reversibility with idarucizumab.

Methods::

Twelve sheep were subjected to 120 min of CPB after anticoagulation with either intravenous dabigatran or heparin (N = 6 per group). In both groups, activated clotting time, kaolin/tissue factor–activated thromboelastography reaction time, and blood gases were monitored during and after CPB. Plasma dabigatran concentrations were measured during and after CPB. After CPB, two sections of each arterial filter were examined for thrombus using electron microscopy. Idarucizumab or protamine was administered after CPB to reverse anticoagulation, and the sheep were monitored for a subsequent 24 h. Plasma concentrations of inflammatory and coagulation markers were assessed at baseline, after 120 min of CPB, and 6 h after reversal administration.

Results::

After 120 min of CPB, there was no visible thrombus or fibrin observed on the arterial line filters in either the dabigatran or heparin groups. Plasma dabigatran concentrations during CPB were below the target concentration (5 µg/ml), ranging from 1.7 ± 0.4 to 3.4 ± 1.5 µg/ml. In both groups, reaction time and activated clotting time values increased during CPB and then returned to nearly baseline levels after administration of the reversal agents. Interleukin-6 concentrations were elevated in the heparin group compared to the dabigatran group. Five sheep survived 24 h after idarucizumab administration. Four of six sheep survived 24 h after the administration of protamine.

Conclusions::

This study demonstrates that dabigatran effectively provides anticoagulation in a sheep CPB model, and idarucizumab successfully reverses its effects.

01 Oct 2025·STROKE

Intravenous Thrombolysis in Patients With Recent Intake of Direct Oral Anticoagulants: A Target Trial Analysis and Comparison With Reversal Agent Use

Article

Author: Boulanger, Marion ; Allardt, Arne ; Stufano, Gianluca ; Longoni, Marco ; Barber, P. Alan ; Yakushiji, Yusuke ; Hahn, Marianne ; Vlachos, Dimitrios ; D’Anna, Lucio ; Lemmens, Robin ; Maes, Louise ; Valente, Mariarosaria ; Giannakakis, Michail ; Riegler, Christoph ; Ceccarelli, Laura ; Rauch, Janis ; Tyson, Alicia ; Siepen, Bernhard ; Piechowiak, Eike ; Touzé, Emmanuel ; Gomez-Exposito, Alexandra ; Auer, Elias ; Davis, Alan J. ; Kurmann, Christoph ; Scoppettuolo, Pasquale ; Cordici, Francesco ; Peeters, André ; Kunieda, Takenobu ; Dittrich, Tolga ; Scutelnic, Adrian ; Paiva Nunes, Ana ; Mujanovic, Adnan ; Dobrocky, Tomas ; Meinel, Thomas R. ; Marto, João Pedro ; Andreone, Vincenzo ; Candelaresi, Paolo ; Aguiar de Sousa, Diana ; Bücke, Philipp ; Seiffge, David J. ; Ghannam, Malik ; Woock, Malin ; Spina, Emanuele ; Valletta, Francesco ; Pfeilschifter, Waltraud ; Thevoz, Guillaume ; De Marchis, Gian Marco ; Kraemer, Christoffer ; Kleeberg, Antonia ; Beyeler, Morin ; Zedde, Marialuisa ; Clenin, Leander ; Frol, Senta ; Guerreiro, Carolina ; Pretnar Oblak, Janja ; Kaesmacher, Johannes ; Alshaer, Qasem N. ; Ntaios, George ; Demeestere, Jelle ; Merlino, Giovanni ; Rodrigues, Bárbara ; Goeldlin, Martina ; Fischer, Urs ; Herrmann, Matthias ; Sökeland, Greta ; Mannino, Marina ; Mariano, Marisa E. ; Alsawareah, Ashraf ; Heldner, Mirjam ; Tudisco, Valentina ; Papadimitriou, Dimitra ; Romoli, Michele ; Uphaus, Timo ; Burini, Alessandra ; Strambo, Davide ; Wu, Teddy Y. ; Ranta, Anna ; Kristoffersen, Espen Saxhaug ; Muppa, Jayachandra ; Padjen, Visnja ; Olalde, Heena ; Henninger, Nils ; Kermer, Pawel ; Michel, Patrik ; Zipser-Mohammadzada, Freschta ; Tentolouris, Vasilis ; Poli, Sven ; Nolte, Christian H. ; Purrucker, Jan C.

BACKGROUND::

Intravenous thrombolysis (IVT) in patients with recent ingestion of direct oral anticoagulants (DOACs) is a frequent challenge and remains controversial. The benefit of DOAC reversal before IVT is uncertain.

METHODS::

Using target trial methodology, we analyzed data from 28 comprehensive stroke centers. Patients on DOACs were included if they met IVT criteria, had a National Institutes of Health Stroke Scale score of ≥2, and last DOAC intake within 48 hours or was undeterminable. Safety and efficacy outcomes (symptomatic intracerebral hemorrhage, any intracerebral hemorrhage, major bleeding, 90-day mortality, and good functional outcome [modified Rankin Scale score of 0–2 or return to baseline]) were compared between those receiving IVT versus no IVT and IVT with versus without reversal. In addition, a comparison was made with patients from the New Zealand stroke registry, all of whom underwent reversal with idarucizumab. We adjusted for covariates known to be associated with safety and efficacy outcomes, including age, stroke severity, intended thrombectomy, blood glucose, blood pressure, DOAC reversal, and time from last intake.

RESULTS::

Overall, 1342 patients fulfilled the target trial criteria. The median age was 80 (interquartile range, 73–86) years, median National Institutes of Health Stroke Scale score was 11, 50% were female, and 52% of patients received endovascular therapy. IVT was given in 342 of 1342 (25%) patients. Of these, 141 (41.2%) had verified DOAC intake <12 hours before admission, and 92 (26.9%) within 12 to 24 hours. Symptomatic intracerebral hemorrhage occurred in 10 of 328 (3.0%) of patients receiving IVT and 54 of 921 (5.9%) patients not receiving IVT (adjusted difference, −2.1% [95% CI, −5.3% to +1.2]). Patients receiving IVT were more likely to have good functional outcomes (adjusted difference, +14.4% [95% CI, +7.1% to +21.8%]). Comparing 289 patients with reversal (from the additional New Zealand registry) and 283 patients without reversal before IVT (from the target trial population), there was no significant difference in symptomatic intracerebral hemorrhage, major bleeding, or efficacy outcomes.

CONCLUSIONS::

This target trial confirms previous observational data regarding the safety of off-label IVT in patients with recent DOAC intake. More data and dedicated trials are needed for patients with confirmed high DOAC plasma levels and regarding the efficacy and safety of DOAC reversal before IVT.

01 Aug 2025·JOURNAL OF EMERGENCY MEDICINE

Prothrombin Complex Concentrate in Direct Oral Anticoagulant Reversal: A Systematic Scoping Review

Article

Author: Nagarajah, Jivanraj ; Yahaya, Hayati Alwani ; Ibrahim, Nazedah Ain ; Tan, Sin Yee ; Tang, Jiaa Yinn ; Tay, Szu Lynn

BACKGROUND:

Direct oral anticoagulants (DOAC) have emerged as an alternative to warfarin for treating venous thromboembolism and stroke prevention in atrial fibrillation. Reversal agents such as idarucizumab and andexanet alfa are not widely and readily available in Malaysia. In their absence, international guidelines recommend the administration of prothrombin complex concentrates (PCC) in life-threatening bleeding caused by DOAC.

OBJECTIVE:

To describe the reported PCC effectiveness and safety in reversing the anticoagulant effects of DOAC and provide better insight into its current practice in Malaysia.

METHODS:

This scoping review was conducted using the following databases: PubMed, Wiley Online Library, Sage Journals, and Google Scholar from 2016 until 2020. Clinical studies focusing on the utilization of PCC in the reversal of DOAC and fulfills the PRISMA extension for Scoping Reviews checklist were included. This review was registered with the National Medical Research Register, Malaysia (NMRR ID-22-01355-DC3).

RESULTS:

The systematic search retrieved 599 studies, 20 of which met the inclusion criteria. All studies described the use of PCC as a reversal agent for DOAC, with doses ranging between 25 and 50 u/kg. Hemostatic effectiveness was reported in 15 studies, 12 of which used the International Society on Thrombosis and Haemostasis (ISTH) criteria. All 20 studies assessed the safety of PCC in terms of overall risk of thrombotic events and mortality.

CONCLUSIONS:

Further high-quality studies are essential to deepen understanding regarding PCC effectiveness and safety in achieving clinical hemostasis. However, this review provides the information regarding PCC as an option when DOAC-specific reversal agents are unavailable, or the type of DOAC is unknown.

News (Medical) associated with Idarucizumab

29 Aug 2025

·www.einpresswire.com

July - September 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr) Hypertension The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2025 to include information about the risk of hypertension. Example: Ajovy labeling Apriso (mesalamine) Asacol (mesalamine) Asacol HD (mesalamine) Azulfidine (sulfasalazine) Azulfidine EN-Tabs (sulfasalazine) Canasa (mesalamine) Colazal (balsalazide disodium) Delzicol (mesalamine) Dipentum (osalazine sodium) Giazo (balsalazide disodium) Lialda (mesalamine) Rowasa (mesalamine) Pentasa (mesalamine) Severe cutaneous adverse reactions The Warnings and Precautions section of the labeling was updated November 2021 to include severe cutaneous adverse reactions. Example: Delzicol labeling Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Pancreatitis FDA determined that no action is necessary at the time based on available information. Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Anaphylactic shock The "Warnings and Precautions" section of the labeling was updated between September 2022 and February 2023 to include anaphylactoid/anaphylactic reactions. Example: Avastin labeling Ayvakit (avapritinib) Photosensitivity reaction The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2023 to include information about photosensitivity. Ayvakit labeling Azacitidine Onureg (azacitidine) Vidaza (azacitidine) Generic products containing azacitidine Pericarditis The "Adverse Reactions" section of the labeling was updated between September 2022 and June 2023 to include pericarditis. Example: Vidaza labeling FDA determined that no action is necessary at the time based on available information for Onureg. Bavencio (avelumab) Imfinzi (durvalumab) Libtayo (cemiplimab-rwlc) Keytruda (pembrolizumab) Opdivo (nivolumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) Tumour lysis syndrome FDA determined that no action is necessary at the time based on available information. Cymbalta (duloxetine hydrochloride) Drizalma Sprinkle (duloxetine hydrochloride) Generic products containing duloxetine hydrochloride Anosmia, Hyposmia This issue is posted as two individual newly identified safety signal (NISS) entries in the January-March 2022 quarter, to reflect the focus on the potential signals of anosmia and hyposmia, separately. Darzalex (daratumumab) Darzalex Faspro (daratumumab and hyaluronidase-fihj) Blood stem cell transplant failure FDA determined that no action is necessary at the time based on available information. Dipeptidyl peptidase-4 (DPP-4) inhibitors Glyxambi (empagliflozin and linagliptin) Janumet (metformin hydrochloride and sitagliptin phosphate) Janumet XR (metformin hydrochloride and sitagliptin phosphate) Jentadueto (linagliptin and metformin hydrochloride) Jentadueto XR (linagliptin and metformin hydrochloride) Kazano (alogliptin and metformin hydrochloride) Kombiglyze XR (metformin hydrochloride and saxagliptin) Nesina (alogliptin) Onglyza (saxagliptin) Oseni (alogliptin and pioglitazone) Steglujan (ertugliflozin and sitagliptin) Tradjenta (linagliptin) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Qtern (saxagliptin and dapagliflozin) Generic products containing dipeptidyl peptidase-4 inhibitors Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated between March 2022 and June 2022 for products containing alogliptin and sitagliptin to include tubulointerstitial nephritis. Example: Janumet labeling FDA determined that no action is necessary for products containing linagliptin and saxagliptin at the time based on available information. *An administrative error resulted in the omission of Januvia from the list of product names after the initial quarterly report was posted. Dupixent (dupilumab) Angioedema The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include angioedema. Dupixent labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua 100/33 (insulin glargine and lixisenatide injection) Trulicity (dulaglutide) Victoza (liraglutide) Wegovy (semaglutide) Xultophy 100/3.6 (insulin degludec and liraglutide injection) Generic products containing glucagon-like peptide-1 analogues Gallbladder related disorders The "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the GLP-1 analogues labeling were updated between March 2022 and June 2022 to include information about acute gallbladder disease. Example: Adlyxin labeling FDA has determined that the last approved labeling for Saxenda and Wegovy is adequately labeled for acute gallbladder disease, and that no further regulatory action is needed at this time. Gonadotropin releasing hormone (GnRH) analogues Fensolvi (leuprolide acetate) Lupron Depot-PED (leuprolide acetate) Supprelin LA (histrelin acetate) Synarel (nafarelin acetate) Triptodur (triptorelin) Idiopathic intracranial hypertension The "Warnings", "Precautions", and "Adverse Reactions" sections of the labeling were updated in April 2022 to include idiopathic intracranial hypertension. Example: Fensolvi labeling Jakafi (ruxolitinib phosphate) Herpes simplex virus (HSV) reactivation and/or disseminated HSV The "Dosage and Administration", "Warnings and Precautions", and "Adverse Reactions" sections of the labeling were updated in January 2023 to include information about herpes simplex and herpes zoster infections. Jakafi labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Embolic and thrombotic events, venous The "Adverse Reactions" section of the Ibrance labeling was updated in December 2024 to include venous thromboembolism. Ibrance labeling FDA determined that no action is necessary at the time for Kisqali and Kisqali Femara Co-Pack based on available information. Ocrevus (ocrelizumab) Myocardial infarction FDA determined that no action is necessary at the time based on available information. Potassium Chloride Product preparation error The “Warnings” section of the labeling was updated in December 2022 to include information about fatal cardiac adverse reactions with intravenous administration of undiluted potassium chloride. Praxbind (idarucizumab) Wrong dose errors The carton labeling and "Dosage and Administration" sections of the labeling were revised in February 2022 to clarify the number of vials included in each carton and the recommended dosing. Praxbind labeling Qbrexza (glycopyrronium tosylate) Accidental exposure to product The container label, carton labeling, "Dosage and Administration", "Warnings and Precautions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in October 2022 to include information about accidental exposure. Qbrexza labeling Qbrexza (glycopyrronium tosylate) Urinary retention The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in October 2022 to include information about new or worsening urinary retention. Qbrexza labeling Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Farxiga (dapagliflozin) Glyxambi (empagliflozin and linagliptin) Invokamet (canagliflozin and metformin hydrochloride) Invokamet XR (canagliflozin and metformin hydrochloride) Invokana (canagliflozin) Jardiance (empagliflozin) Qtern (saxagliptin and dapagliflozin) Steglatro (ertugliflozin) Steglujan (ertugliflozin and sitagliptin) Segluromet (ertugliflozin and metformin hydrochloride) Synjardy (empagliflozin and metformin hydrochloride) Synjardy XR (empagliflozin and metformin hydrochloride) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Xigduo XR (dapagliflozin and metformin) Generic products containing sodium-glucose cotransporter-2 (SGLT-2) inhibitors Tubulointerstitial nephritis FDA determined that no action is necessary at the time based on available information. Somatostatin Receptor Imaging Agents Detectnet (copper Cu-64 dotatate injection) Gallium Dotatoc (GA 68) Octreoscan (Indium In 111 Pentetreotide) Netspot (Gallium GA 68 Dotatate) Hypersensitivity The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include hypersensitivity reactions. Example: Netspot labeling Stromectol (ivermectin) Generic products containing ivermectin Off label use FDA determined that no action is necessary at the time based on available information. Stromectol (ivermectin) Generic products containing ivermectin Neurotoxicity The "Warnings", "Adverse Reactions", and "Overdosage" sections of the labeling were updated in March 2022 to include neurotoxicity. Example: Stromectol labeling Sunosi (solriamfetol hydrochloride) Hypersensitivity FDA determined that no action is necessary at the time based on available information. Vivitrol (naltrexone) Incorrect route of product administration The container label (vial), carton labeling, "Dosage and Administration", "Warnings and Precautions", and "Description", sections of the labeling were revised in September 2022 to emphasize the appropriate route and site of administration. Vivitrol labeling Xcopri (cenobamate) Psychiatric disorders The "Adverse Reactions" section of the labeling was updated in June 2022 to include psychiatric disorders. Xcopri labeling 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.

Drug Approval

11 Sep 2024

·www.biospace.com

Feinstein Institutes Research Suggests New Management Protocols for Patients Taking Oral Anticoagulants

MANHASSET, N.Y.--(BUSINESS WIRE)--Direct oral anticoagulants (DOACs) are commonly used medications that help prevent blood clots, which can be dangerous for those suffering from heart conditions or at risk of venous thromboembolism. However, these medications can also increase the likelihood of bleeding, especially during surgeries. Researchers at the Feinstein Institutes for Medical Research recently published in the Journal of the American Medical Association (JAMA) protocols to effectively manage the administration of DOACs and minimize bleeding and clotting risks – suggesting new conventions for patients pre- and post-surgery. Approximately 4 million patients in the United States are currently being treated with DOAC therapy. The review paper, titled “Perioperative Management of Patients Taking Direct Oral Anticoagulants,” analyzed how physicians should handle a patient’s blood thinner medicine depending on whether a procedure is surgical and to what degree of risk a procedure presents. The paper reviewed 99 articles on blood thinners and surgery to inform its evaluation. The authors concluded that doctors must assess the bleeding risk (low, medium, or high) of a planned surgery. Additionally, the research recommends that standardized management protocols – which do not require testing DOAC levels, heparin bridging, or short-acting anticoagulants – can be safely and effectively used for patients undergoing elective or non-urgent procedures. However, for patients on DOACs who require emergency, urgent, or semi-urgent surgery, using anticoagulant reversal agents may be appropriate if DOAC levels are elevated or unavailable. “When patients taking DOAC blood thinners undergo an optional or nonsurgical procedure, doctors can follow a simple standardized management plan where they won’t need to administer a blood test to check DOAC levels or use heparin, an alternate blood thinner,” said Alex C. Spyropoulos, MD , professor at Feinstein Institutes’ Institute of Health System Science . “Through this careful review, we determine that urgent or emergent procedures are another story and may need additional therapy and monitoring to prevent complications.” Patients who require urgent or emergency surgeries may need additional medications that quickly reverse the effects of DOACs if bleeding occurs during the procedure. One type of reversal agent (examples include andexanet-α for edoxaban, rivaroxaban , or apixaban and idarucizumab for dabigatran) can help with specific DOACs, while a more general reversal agent called prothrombin complex concentrate (PCC) can reverse the effects of any DOAC medication, albeit less effectively. “A leader in the field, Dr. Spyropoulos advances patient care through his research,” said Kevin J. Tracey, MD , president and CEO of the Feinstein Institutes and the Karches Family Distinguished Chair in Medical Research at Northwell Health. “His new insights into preventing life-threatening blood clots during elective procedures have the potential to benefit countless patients at Northwell Health and globally.” In addition to this JAMA article, and investigating a blood clot prevention treatment called thromboprophylaxis – particularly in relation to the treatment of hospitalized COVID-19 patients – Dr. Spyropoulos and his co-authors recently published an article in the Journal of Thrombosis and Haemostasis that determined hospitals’ incorporation of a user-friendly clinical decision support tool can also significantly improve the appropriate use of blood clot prevention strategies. About the Feinstein Institutes The Feinstein Institutes for Medical Research is the home of the research institutes of Northwell Health, the largest health care provider and private employer in New York State. Encompassing 50 research labs, 3,000 clinical research studies and 5,000 researchers and staff, the Feinstein Institutes raises the standard of medical innovation through its six institutes of behavioral science, bioelectronic medicine, cancer, health system science, translational research, and molecular medicine. We make breakthroughs in health condition, including endometriosis, lupus, postpartum depression, schizophrenia, sepsis. We are the global scientific leader in bioelectronic medicine – an innovative field of science that has the potential to revolutionize medicine. For more information about how we produce knowledge to cure disease, visit and follow us on LinkedIn . Contacts Matthew Libassi 631-793-5325 mlibassi@northwell.edu

13 Nov 2023

·synapse.patsnap.com

Analysis on the Clinical Research Progress of Fab Fragment

The Fab fragment, also known as the antigen-binding fragment, is the region of an antibody that can bind with antigens. The Fab fragment consists of a complete light chain and the VH and CH1 structural domains (Fd segment) of the heavy chain, with a molecular weight of approximately 50,000. Both the light and heavy chains contain a constant region and a variable region, with disulfide bonds linking the two chains. As Fab possesses both an antigen-binding site and a part of the constant region, it not only has the same antibody-antigen affinity and excellent tissue penetration ability as a single-chain antibody (scFv), but also a more stable structure. Therefore, it plays a significant role in clinical diagnosis and treatment. Compared with the complete IgG, the Fab fragment lacks the Fc region and, although it can selectively bind to the antigen, it does not precipitate. Due to its low autoimmunogenicity, it can't be recognized by living immune cells, thereby significantly reducing the likelihood of hypersensitivity reactions and enhancing the safety of a product. Fab-class antibody fragments have the characteristics of low molecular weight, strong tissue distribution specificity, low immunogenicity, and manipulability through gene engineering, making Fab an essential member in the field of pharmaceutical research. Fab-class drugs are widely applied in prevention, diagnosis, and treatment fields. Fab Fragment Competitive LandscapeAccording to Patsnap Synapse, as of 8 Oct 2023, there are a total of 69 Fab fragment drugs worldwide, from 115 organizations, covering 35 targets, 110 indications, and conducting 918 clinical trials. 👇Please click on the picture link below for free registration or login directly if you have freemium accounts, you can browse the latest research progress on drugs , indications, targets, organizations, clinical trials, and clinical results related to this drug type. Approved Fab Fragment Medicinal: IdarucizumabIdarucizumab is a drug that falls under the category of Fab fragment, monoclonal antibody in the field of biomedicine. It is designed to target dabigatran, a medication used to prevent blood clots. The therapeutic areas in which Idarucizumab is used include hemic and lymphatic diseases, as well as other diseases. The drug is primarily indicated for the treatment of blood coagulation disorders and hemorrhage. Idarucizumab was developed by Boehringer Ingelheim GmbH, a pharmaceutical company. It has received approval for use in the highest phase globally, indicating that it has successfully completed clinical trials and met the necessary regulatory requirements. The first approval of Idarucizumab took place in the United States in October 2015. This signifies that it was the first country to grant regulatory approval for the drug. Additionally, Idarucizumab is classified as an orphan drug, which means it is intended to treat rare diseases or conditions that affect a small number of individuals. In summary, Idarucizumab is a Fab fragment, monoclonal antibody drug developed by Boehringer Ingelheim GmbH. It targets dabigatran and is used in the treatment of blood coagulation disorders and hemorrhage. The drug has received approval in global markets, with its first approval occurring in the United States in October 2015. Idarucizumab is classified as an orphan drug, indicating its intended use for rare diseases or conditions. 👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug. Approved Fab Fragment Medicinal: Certolizumab PegolCertolizumab Pegol is a drug that falls under the category of Fab fragment, Monoclonal antibody. It specifically targets TNF-α, which is a protein involved in the immune system response. The drug has been approved for use in various therapeutic areas, including Immune System Diseases, Congenital Disorders, Hemic and Lymphatic Diseases, Nervous System Diseases, Skin and Musculoskeletal Diseases, Infectious Diseases, and Digestive System Disorders. Certolizumab Pegol has been indicated for the treatment of several conditions, such as Erythrodermic psoriasis, Psoriasis vulgaris, Pustular psoriasis, Non-radiographic axial spondyloarthritis, Ankylosing Spondylitis, Plaque psoriasis, Arthritis (Psoriatic and Rheumatoid), Axial Spondyloarthritis, Crohn Disease, Psoriasis, Multiple Sclerosis, and Granulomatous Disease, Chronic. The drug was developed by UCB SA, an originator organization in the pharmaceutical industry. It has received approval in multiple countries, with its first approval granted in the United States in April 2008. Certolizumab Pegol has undergone priority review, indicating its potential significance in addressing unmet medical needs or providing a substantial improvement over existing treatments. As a Fab fragment, Monoclonal antibody targeting TNF-α, Certolizumab Pegol offers a promising therapeutic option for a wide range of diseases affecting various body systems. Its approval in multiple countries, including the United States, highlights its effectiveness and safety profile. The drug's diverse therapeutic areas indicate its potential to address multiple medical conditions, ranging from immune system disorders to digestive system disorders. Certolizumab Pegol's approval in China further expands its reach and potential patient population. The drug's highest phase being approved globally signifies its advanced stage of development and successful clinical trials. With its first approval dating back to 2008, Certolizumab Pegol has established a significant presence in the pharmaceutical market, providing healthcare professionals and patients with a valuable treatment option. 👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug. Overall, Certolizumab Pegol's approval, therapeutic areas, and target specificity make it a noteworthy drug in the field of biomedicine. Its originator organization, UCB SA, has contributed to the advancement of pharmaceutical research and development, bringing innovative therapies to patients worldwide.

100 Deals associated with Idarucizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10741	Idarucizumab	V03AB37	DB09264

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hemorrhage	United States	Boehringer Ingelheim Pharmaceuticals, Inc.	16 Oct 2015

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Venous Thromboembolism	Phase 3	Russia	Boehringer Ingelheim GmbH	07 Sep 2016

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ISTH2023	Not Applicable	-	3,465	Idarucizumab	vtkvbwzybh(ybozaxkqwx) = oklghhlfje jqkhkiahac (jsiymhkmha, 11.5 - 19.6) View more	-	24 Jun 2023
ISTH2022	Not Applicable	-	101	Idarucizumab	cxuxzzdwux(fvjqdcuojt) = mornrqyipf zlhthvwjmb (fgarmwueth )	-	09 Jul 2022
ISTH2022	Not Applicable	-	46	Idarucizumab	baqnxucmpo(jtjjpalcmy) = vxgmuhnmml pkhuzfwalu (rjdosvjfze )	-	09 Jul 2022
NCT03343704 (CTgov)	Phase 3	Hemorrhage	19	Idarucizumab (Group A - Patients With Uncontrolled or Life-threatening Bleeding)	poganlzpwk(ruicdbtpoy) = lhuiyojpwe yrdkzufhya (umttlhodoz, bzypsosixw - kwnjmimllv) View more	-	20 Aug 2021
NCT03343704 (CTgov)	Phase 3	Hemorrhage	19	Idarucizumab (Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure)	poganlzpwk(ruicdbtpoy) = tjligumomi yrdkzufhya (umttlhodoz, vejzdpccqc - ujhbkvgnpv) View more	-	20 Aug 2021
ISC2021	Not Applicable	Hemorrhage	-	Idarucizumab	ywitjrpjfb(abvgcyehrz) = iylxltbqfw rpowanbsns (filbgzaogu )	-	01 Mar 2021
ISC2021	Not Applicable	Hemorrhage	-	Andexanet Alfa	ywitjrpjfb(abvgcyehrz) = phsdusannk rpowanbsns (filbgzaogu )	-	01 Mar 2021
NCT03086356 (Pubmed \| Adv Ther)	Phase 1	-	12	Dabigatran etexilate + Idarucizumab	bvivcivezq(ruzlzfcekr) = close to zero for all coagulation parameters fwacgurebq (qnpojqligu )	-	20 Jul 2020
NCT02815670 (CTgov)	Phase 3	Hemorrhage \| Venous Thromboembolism	1	Idarucizumab	owdmxxrozt = jqqwskgwpv ucabpzirrn (bxkjtagggd, kzraytsxvr - nzjifmngci) View more	-	14 Apr 2020
NCT02104947 (Reversal of Dabigatran Anticoagulant Effect With Idarucizumab, Pubmed \| J Am Coll Cardiol)	Phase 3	Renal Insufficiency	503	Dabigatran-treated nondialysis patients with normal renal function	ysnscoivzm(knhnghwvnx) = vtqdjcgsbg vsuyyoolet (vudihyzjzm )	-	08 Oct 2019
	Phase 3	Renal Insufficiency	503	Dabigatran-treated nondialysis patients with mild renal impairment	ysnscoivzm(knhnghwvnx) = zckncritau vsuyyoolet (vudihyzjzm )	-	08 Oct 2019
EAN2019	Not Applicable	Intracranial Hemorrhages \| Brain Ischemia	-	Idarucizumab	tbvypeepoj(ndlbdhyytu) = bbvewmjfhq kptcajdpcm (fmkkmrefvv ) View more	-	27 Jun 2019
EAN2019	Not Applicable	Intracranial Hemorrhages \| Brain Ischemia	-	Dabigatran	tbvypeepoj(ndlbdhyytu) = wolvnwgsnm kptcajdpcm (fmkkmrefvv )	-	27 Jun 2019
ISTH2019	Not Applicable	-	41	Idarucizumab	mfetzznsoe(ilteeywhab) = ozfmltuyke nwdscytmhv (veqwibezuo ) View more	-	10 Jun 2019

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