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

547

Literatures (Medical) associated with Idarucizumab

01 Jul 2026·PERFUSION-UK

Dabigatran-idarucizumab pharmacokinetics-pharmacodynamics in sheep undergoing cardiopulmonary bypass

Article

Author: Anderson, Brian J ; Stefanos, Tatsiana ; Eaton, Michael P ; Nadtochiy, Sergiy M

Background:

The effect of the anticoagulant, dabigatran, and its antagonist, idarucizumab, on coagulation remains poorly quantified. There are few pharmacokinetic-pharmacodynamic data available to describe the interaction in humans or animals undergoing cardiopulmonary bypass.

Methods:

Six sheep were given intravenous dabigatran infusion while undergoing cardiopulmonary bypass. Blood samples were collected for thromboelastographic reaction time (R-time) and drug assay at 1. 5, 15, 30, 60, 90, and 120 min after starting dabigatran. Further reaction times were measured at 1 min, 5 min, 15 min, 60 min, 4 h and 24 h after initiation of idarucizumab infusion. Plasma dabigatran concentrations, the dabigatran- idarucizumab interaction and R-times were analyzed using an integrated pharmacokinetic-pharmacodynamic model with non-linear mixed effects.

Results:

A 2-compartment model described dabigatran pharmacokinetics with a clearance (CL 0.0509 L/min/70 kg), intercompartment clearance (Q 0.229 L/min/70 kg), central volume of distribution (V1 3.89 L/70 kg), peripheral volume of distribution (V2 11.4 L/70 kg). The peripheral volume was 2.25 times larger during bypass. The effect compartment model estimates for an E MAX model using reaction time had an effect site concentration (Ce 50 40.8 mg/L) eliciting half of the maximal effect (E MAX 180 min). A potency factor for the antagonist, idarucizumab (EA 50 29.9 mg/L), moved the dabigatran response relationship to the left.

Conclusions:

Dabigatran reversibly binds to the active site on the thrombin molecule, preventing activation of coagulation factors. Expansion of peripheral volume of distribution of dabigatran was observed during cardiopulmonary bypass, contributing to observed concentrations lower than predicted. A competitive interaction model adequately described dabigatran reversal by idarucizumab. These data and consequent parameter estimates inform future clinical studies in both animals and humans.

11 Jun 2026·NEW ENGLAND JOURNAL OF MEDICINE

Antidotes for Anticoagulation Reversal

Review

Author: ten Cate, Hugo ; Rocca, Bianca

The global rise in anticoagulant use has increased the number of major bleeding events that warrant timely and effective pharmacologic reversal. Reversal strategies should be informed by the pharmacodynamic and pharmacokinetic features of the anticoagulant and antidote, regulatory indications, quality of evidence, patient-specific factors, and availability of treatment options. Protamine sulfate neutralizes unfractionated heparin, whereas no specific antidotes exist for low-molecular-weight heparins or fondaparinux. Four-factor prothrombin complex concentrates effectively reverse vitamin K antagonists. Idarucizumab specifically reverses dabigatran, although delayed dabigatran rebound can occur. Andexanet alfa targets direct oral factor Xa inhibitors, but uncertainties regarding the efficacy-safety balance, monitoring, rebound, perioperative use, and cost have prompted off-label use of four-factor prothrombin complex concentrates, for which stronger evidence is needed. Key challenges remain, including determination of appropriate dosing, standardization and validation of laboratory monitoring, mitigation of thrombotic risk, and development of guidelines for perioperative treatment. Emerging agents aim to broaden targets and improve safety. Building high-quality evidence remains essential to advancing global, patient-centered anticoagulant and hemostatic care.

09 Jun 2026·NEUROLOGY

Safety and Outcomes of Dabigatran Reversal With Idarucizumab Before IV Thrombolysis in Patients With Acute Ischemic Stroke

Article

Author: Moreira, Tiago Prazeres ; Ahmed, Niaz ; Rota, Eugenia ; Tsivgoulis, Georgios ; Toni, Danilo ; Säflund, Malin ; Kiamili, Argyro ; Chiti, Alberto ; Matusevicius, Marius ; Frol, Senta ; Peeters, André ; Petruzzellis, Marco

BACKGROUND AND OBJECTIVES:

IV thrombolysis (IVT) is contraindicated in patients with acute ischemic stroke (AIS) while on dabigatran or other oral anticoagulant (OAC) treatment. Idarucizumab completely reverses the effect of dabigatran within minutes, without increasing the risk of thromboembolism. Limited data exist on IVT treatment after dabigatran reversal with idarucizumab. We aimed to investigate the safety and outcomes of IVT after dabigatran reversal in patients with AIS.

METHODS:

This is an observational study based on the Safe Implementation of Treatment in Stroke (SITS) International Stroke Thrombolysis Registry. Hospitals treating patients with AIS contributed data. The main outcome was safety as measured by any parenchymal hematoma (PH), symptomatic intracerebral hemorrhage (SICH) per SITS, and death within 3 months. The secondary outcome was functional independence defined as modified Rankin Scale scores of 0-2 at 3 months. Propensity score matching (PSM) was used to compare patients treated with dabigatran reversal to patients without prior OAC in primary analysis and for secondary analysis between patients treated with dabigatran reversal with idarucizumab to patients on dabigatran without reversal treatment.

RESULTS:

Among 258,589 IVT treated patients with AIS, 510 were on dabigatran and 156 received dabigatran reversal. Dabigatran reversal patients were older (75 vs 69 years, p < 0.01), had similar median baseline NIH Stroke Scale (9 vs 10, p = 0.47), and longer onset to IVT time (185 vs 150 minutes, p < 0.01) compared with patients without prior OAC treatment (n = 191,648). After PSM analysis where good balance was achieved, patients treated with dabigatran reversal before IVT had similar results in all outcomes as compared with patients treated with IVT without prior OAC (any PH: 3 vs 9%, p = 0.10; SICH: 1 vs 1%, p = 1.00; death: 25 vs 19%, p = 0.33, functional independence: 51 vs 52%, p = 0.95). Secondary analysis showed similar results for all outcomes before and after PSM.

DISCUSSION:

In our observational study with patients with AIS, IVT treatment after dabigatran reversal was safe and had similar outcomes to IVT treatment without previous OAC. Furthermore, comparison between dabigatran reversal vs no reversal also indicates that IVT is safe for patients on dabigatran without idarucizumab reversal, which is currently being investigated in clinical trials.

CLASSIFICATION OF EVIDENCE:

This study provides Class III evidence that IVT after idarucizumab reversal in patients with AIS who took dabigatran within 48 hours of onset of symptoms is safe and comparable with those of patients with AIS not on prior oral anticoagulation.

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 Aug 2024

·www.octapharma.com

Improving care for AF Patients: Managing factor Xa inhibitor bleeding risks in urgent surgery

As part of our ongoing commitment to cutting-edge research and patient care, Octapharma has been supporting the PROXY trial, aimed at evaluating whether preoperative 4-factor prothrombin complex concentrate (4F-PCC) can prevent excessive bleeding during emergency surgery in patients on therapeutic levels of oral factor Xa (FXa) inhibitors, without increasing thrombotic risk. In the rapidly evolving landscape of anticoagulation therapy, direct oral anticoagulants (DOACs) have significantly improved the management of atrial fibrillation (AF). These drugs, which target Factor IIa (in the case of dabigatran) and FXa (in the case of rivaroxaban and apixaban), offer a more predictable dose-response relationship and a broader therapeutic index compared to warfarin. This advancement means patients can enjoy the convenience of fixed dosing without the frequent need for blood monitoring, thereby enhancing their overall quality of life. However, despite these benefits, DOACs pose challenges, especially in managing bleeding during urgent surgical procedures.1-4 Patients with AF on anticoagulants often require surgery that requires pausing their medication. The RE-LY trial report (2009) showed that 2% of participants needed such procedures over two years5. Dabigatran users benefit from a reversal agent, idarucizumab, which provides a crucial safety net in emergencies.6 For those taking FXa inhibitors, managing bleeding risks becomes more complex. Andexanet alfa, a direct reversal agent, and 4F-PCC have both been used to address major bleeding associated with FXa inhibitors. A recent meta-analysis highlighted similar efficacy and safety profiles for these treatments7. However, the optimal approach before urgent surgery remains uncertain due to limited data and the rare preoperative quantification of FXa inhibitor levels in blood. Most guidelines recommend a “wait and see” strategy whenever possible8, which involves postponing surgery to allow for the clearance of the FXa inhibitor and using a reversal agent if bleeding occurs. To explore this clinical challenge, Professor Sam Schulman conducted the PROXY trial, a phase 2, investigator-initiated, prospective single-arm study across three Canadian centres, supported by Octapharma9, to evaluate whether preoperative 4F-PCC can prevent excessive bleeding during emergency surgery in patients taking oral FXa inhibitors, without increasing thrombotic risk. The findings were promising: the majority of patients (16 out of 20) presented normal or near-normal haemostasis during surgery, with only a few presenting moderately (2 out of 20) or severely (2 out of 20) abnormal haemostasis. Notably, only one asymptomatic thrombotic event was identified, the cause of which remains unclear. While larger trials with control groups are necessary to confirm these findings, the results suggest that reversing clinically relevant levels of FXa inhibitors with 4F-PCC could benefit patients prior to their undergoing high-risk urgent surgery. The leading Journal of Thrombosis and Haemostasis (JTH) has published results from the PROXY study. The results are available online, with open access. References: 1. Harter K, Levine M, Henderson SO. Anticoagulation drug therapy: a review. West J Emerg Med. 2015;16(1):11–17. 2. Becattini C, Vedovati MC, Agnelli G. Old and new oral anticoagulants for venous thromboembolism and atrial fibrillation: a review of the literature. Thromb Res. 2012;129(3):392–400. 3. Mueller S, Groth A, Spitzer SG, et al. Real-world effectiveness and safety of oral anticoagulation strategies in atrial fi brillation: a cohort study based on a German claims dataset. Pragmat¬Obs Res. 2018;9:1–10. 4. Rodriguez-Bernal CL, Peiro S, Hurtado I, et al. Primary nonadherence to oral anticoagulants in patients with atrial fi brillation: real-world data from a population-based cohort. J¬Manag Care Spec Pharm. 2018;24(5):440–448. 5. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009 Sep 17;361(12):1139-51. doi: 10.1056/NEJMoa0905561. Epub 2009 Aug 30. Erratum in: N Engl J Med. 2010 Nov 4;363(19):1877. PMID: 19717844. 6. Pollack CV Jr, Reilly PA, van Ryn J, Eikelboom JW, Glund S, Bernstein RA, Dubiel R, Huisman MV, Hylek EM, Kam CW, Kamphuisen PW, Kreuzer J, Levy JH, Royle G, Sellke FW, Stangier J, Steiner T, Verhamme P, Wang B, Young L, Weitz JI. Idarucizumab for Dabigatran Reversal - Full Cohort Analysis. N Engl J Med. 2017 Aug 3;377(5):431-441. doi: 10.1056/NEJMoa1707278. Epub 2017 Jul 11. PMID: 28693366. 7. Nederpelt CJ, Naar L, Krijnen P, le Cessie S, Kaafarani HMA, Huisman MV, et al. Andexanet alfa or prothrombin complex concentrate for factor Xa inhibitor reversal in acute major bleeding: a systematic review and meta-analysis. Crit Care Med. 2022; 49: e1025-e36 8. Grottke, Oliver; Afshari, Arash; Ahmed, Aamer; Arnaoutoglou, Eleni; Bolliger, Daniel; Fenger-Eriksen, Christian; von Heymann, Christian. Clinical guideline on reversal of direct oral anticoagulants in patients with life threatening bleeding. European Journal of Anaesthesiology 41(5):p 327-350, May 2024 9. Schulman S, et al. Prothrombin complex concentrate for emergency surgery in patients on oral Xa-inhibitors. J Thromb Haemost. 2024 Jul 11:S1538-7836(24)00386-6 Bleeding management Critical care

Clinical ResultPhase 2

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	odkvzpxqxi(nyavxjuadj) = lchskqclqd uansxgabuo (fnkzqcmmwh, 11.5 - 19.6) View more	-	24 Jun 2023
ISTH2022	Not Applicable	-	101	Idarucizumab	sdlhvkayax(fnizguldng) = qchzwjgnhy mpjswsixbx (vhaznxdsrf )	-	09 Jul 2022
ISTH2022	Not Applicable	-	46	Idarucizumab	vlqciorhpq(tmchaaklab) = grnwzfyjwo pknyldxqgg (fzeardcyrq )	-	09 Jul 2022
NCT03343704 (CTgov)	Phase 3	Hemorrhage	19	Idarucizumab (Group A - Patients With Uncontrolled or Life-threatening Bleeding)	anbzbcgezn(vwesvpsyqr) = uvsukcspoi wtzqkqasbf (oiogfwqnld, dyvmlxihqz - uwnoliisas) View more	-	20 Aug 2021
NCT03343704 (CTgov)	Phase 3	Hemorrhage	19	Idarucizumab (Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure)	anbzbcgezn(vwesvpsyqr) = lfudkuylwk wtzqkqasbf (oiogfwqnld, eqmgixfioo - vesjffmehy) View more	-	20 Aug 2021
ISC2021	Not Applicable	Hemorrhage	-	Idarucizumab	njkpbhhphm(cjgwmrhdlj) = beobzixcse cinokvnebf (ylgdrygvqb )	-	01 Mar 2021
ISC2021	Not Applicable	Hemorrhage	-	Andexanet Alfa	njkpbhhphm(cjgwmrhdlj) = skqtxmxzfm cinokvnebf (ylgdrygvqb )	-	01 Mar 2021
NCT03086356 (Pubmed \| Adv Ther)	Phase 1	-	12	Dabigatran etexilate + Idarucizumab	oceteuuppt(hyqlysqybj) = close to zero for all coagulation parameters leuhvicrbh (frojmxgeym )	-	20 Jul 2020
NCT02815670 (CTgov)	Phase 3	Hemorrhage \| Venous Thromboembolism	1	Idarucizumab	pqmbqvuvbf = fszsvofbfb cypfntofur (yrfnnsaaug, mdcylcalod - zhaeonuxsr) 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	btsonkhqcj(qstxsapeik) = mqjczxuvos rjattzeijv (bmxrrsywsm )	-	08 Oct 2019
	Phase 3	Renal Insufficiency	503	Dabigatran-treated nondialysis patients with mild renal impairment	btsonkhqcj(qstxsapeik) = npkhnmfprq rjattzeijv (bmxrrsywsm )	-	08 Oct 2019
EAN2019	Not Applicable	Intracranial Hemorrhages \| Brain Ischemia	-	Idarucizumab	cdnkmkjhkv(qfnqwlprdy) = vtzrvsaytd kzgmrjxqke (lipfegzlle ) View more	-	27 Jun 2019
EAN2019	Not Applicable	Intracranial Hemorrhages \| Brain Ischemia	-	Dabigatran	cdnkmkjhkv(qfnqwlprdy) = whteukyati kzgmrjxqke (lipfegzlle )	-	27 Jun 2019
ISTH2019	Not Applicable	-	41	Idarucizumab	wvsdnhalxa(aadjseattu) = wqyppicopy xozjyhydvi (ktrdrfniok ) View more	-	10 Jun 2019

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