Drugs / Dabigatran
Dabigatran
also known as
Pradaxa · Dabigatran (Pradaxa) · BIBR 953 ZW · dabigatran etexilate · dabigatran etexilate mesylate · Dabigatrana · Dabigatranetexilat · Pradaxa is the brand name for dabigatran
targets F2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed puerperal pulmonary embolism 3 milestones | |||||
| Filed | US (FDA) | PRADAXA | puerperal pulmonary embolism | 2013-12-17 | “the U.S. Food and Drug Administration accepted for review a supplemental New Drug Application (sNDA) for PRADAXA for its use in patients with DVT or PE.” prnewswire.com ↗ |
| Filed | US (FDA) | Pradaxa | puerperal pulmonary embolism | 2013-08-28 | “The company recently announced it submitted applications to U.S. and EU regulatory authorities to review dabigatran for its use in patients with DVT and PE.” prnewswire.com ↗ |
| Filed | EU (EMA) | Pradaxa | puerperal pulmonary embolism | — | “The company recently announced it submitted applications to U.S. and EU regulatory authorities to review dabigatran for its use in patients with DVT and PE.” prnewswire.com ↗ |
| Filed Indication not stated 1 milestone | |||||
| Filed | US (FDA) | Pradaxa | deep venous thrombosis and pulmonary embolism prophylaxis | 2015-04-06 | “FDA filed a supplemental New Drug Application (sNDA) for Pradaxa ® (dabigatran etexilate mesylate)” prnewswire.com ↗ |
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News releases announcing trial results or a regulatory action · 39
| Date | Issuer | Release |
|---|---|---|
| 2024-03-25 | Bristol-Myers Squibb | Results Bristol Myers Squibb to Present Data at the American College of Cardiology Annual Scientific Session 2024 Reinforcing Extensive Body of Evidence in Clinical and Real-World Settings Across Cardiovascular Portfolio bms.com ↗ |
| 2021-11-01 | Alembic Pharmaceuticals Ltd. | Regulatory Press Release USFDA Tentative Approval Dabigatran Etexilate Capsules alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules, 150 mg. |
| 2020-12-21 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives ANDA tentative approval for Dabigatran Etexilate Capsules, 75 mg, 110 mg, and 150 mg glenmarkpharma.com ↗
Glenmark Pharmaceuticals Ltd (Glenmark) has received tentative approval by the United States Food & Drug Administration (U.S. FDA) for Dabigatran Etexilate Capsules, 75 mg, 110 mg, and 150 mg, the generic version of Pradaxa®1 Capsules, 75 mg, 110 mg, and 150 mg, of Boehringer Ingelheim Pharmaceuticals, Inc. |
| 2019-09-01 | Bristol-Myers Squibb | Results Findings Released from NAXOS, a French Real-World Data Analysis and the Largest Real-World Data Analysis on Oral Anticoagulant Effectiveness and Safety in Europe Among Patients with Non-Valvular Atrial Fibrillation bms.com ↗
Results show Eliquis was associated with a lower rate of major bleeding and comparable rates of stroke and systemic thromboembolic events versus dabigatran or rivaroxaban |
| 2019-07-08 | Boehringer Ingelheim | Results New data show efficacy and safety of Pradaxa® in the management of VTE in children prnewswire.com ↗
The Phase IIb/III DIVERSITY study showed Pradaxa to be as effective and to have a comparable safety profile to the current standard of care (SOC) for the treatment of acute venous thromboembolism (VTE) in children. |
| 2018-11-11 | Bristol-Myers Squibb | Results Real-World Evidence on Patients Aged 80 and Older Presented From ARISTOPHANES, the Largest Real-World Data Study Evaluating Oral Anticoagulants Among Patients with Non-Valvular Atrial Fibrillation bms.com ↗
Eliquis ® (apixaban) was associated with lower rates of stroke or systemic embolism and major bleeding in elderly patient populations when compared to rivaroxaban and dabigatran |
| 2018-03-11 | Pfizer | Results Findings Released from Largest Real-World Data Analysis of Non-Valvular Atrial Fibrillation Patients Receiving Direct Oral Anticoagulants pfizer.com ↗
This is the largest RWD analysis reporting outcomes among different direct oral anticoagulants (DOACs), including Eliquis® (apixaban), rivaroxaban and dabigatran, to date. |
| 2018-03-11 | Bristol-Myers Squibb | Results Findings Released from Largest Real-World Data Analysis of Non-Valvular Atrial Fibrillation Patients Receiving Direct Oral Anticoagulants bms.com ↗
Eliquis ® (apixaban) use was associated with lower rates of stroke or systemic embolism and major bleeding than matched patients receiving rivaroxaban or dabigatran |
| 2018-01-25 | Boehringer Ingelheim | Results New Real-World Analysis Finds Lower Risk of Major Bleeding and Similar Risk of Stroke with Standard Dose of Pradaxa® Compared to Rivaroxaban in NVAF Patients Newly Initiating Treatment prnewswire.com ↗ |
| 2017-08-27 | Boehringer Ingelheim | Results RE-DUAL PCI™ Results Offer Favorable New Safety Data on Pradaxa® prnewswire.com ↗
The findings were presented today at a late-breaking spotlight session at the European Society of Cardiology (ESC) Congress 2017 in Barcelona, Spain and simultaneously published in the New England Journal of Medicine . |
| 2017-07-11 | Boehringer Ingelheim | Results Final Phase III Study Results Reinforces Safety and Efficacy of Praxbind® as Reversal Agent for Pradaxa® Patients in Emergency Situations prnewswire.com ↗
Reversal was independent of age, sex, kidney function or dabigatran concentration at baseline. |
| 2017-03-19 | Boehringer Ingelheim | Results Uninterrupted Pradaxa® (dabigatran etexilate mesylate) Showed Less Major Bleeding than Warfarin in Atrial Fibrillation Patients Undergoing Catheter Ablation prnewswire.com ↗
In the RE-CIRCUIT trial, uninterrupted PRADAXA significantly reduced the risk of major bleeding complications compared with uninterrupted warfarin. |
| 2017-02-24 | Boehringer Ingelheim | Results Real-World Data from Boehringer Ingelheim Show Lower Risk of Stroke and Major Bleeding for Pradaxa® (dabigatran etexilate mesylate) Compared to Warfarin prnewswire.com ↗
Compared to warfarin, PRADAXA was associated with a 26 percent reduced risk of stroke (HR, 0.74; 95% Cl, 0.58-0.94) and a 20 percent reduced risk of major bleeding (HR, 0.80; 95% Cl, 0.69-0.92). |
| 2016-11-15 | Boehringer Ingelheim | Results Updated Phase III Results Reinforce Safety and Efficacy of Praxbind® (idarucizumab) in Urgent Situations prnewswire.com ↗
The primary endpoint of reversal of the anticoagulant effect of dabigatran within four hours was 100 percent, as measured by diluted thrombin time (dTT) and ecarin clotting time (ECT) (95% CI, 100-100). |
| 2016-11-14 | Boehringer Ingelheim | Results First Data from Boehringer Ingelheim, Anthem and HealthCore Multi-Year Study Show Gaps in Non-valvular Atrial Fibrillation Care prnewswire.com ↗
Although treatment guidelines recommend OAC treatment for all NVAF patients at high stroke risk (i.e., CHADS 2 score ≥2), researchers found less than half (41.1 percent) of the study patients were treated with an OAC (warfarin, dabigatran, rivaroxaban or apixaban). |
| 2016-08-29 | Boehringer Ingelheim | Results ESC Congress 2016 Late Breaking Science Registry: Latest Data on Pradaxa® (dabigatran etexilate mesylate) Safety and Effectiveness Profile Show Low Rates of Bleeding and Stroke in NVAF Patients in Routine Clinical Care prnewswire.com ↗
First outcome results from the GLORIA™-AF Registry show that treatment with Pradaxa® (dabigatran etexilate mesylate) was associated with low incidences of stroke, major bleeding and life-threatening bleeding. |
| 2016-04-02 | Boehringer Ingelheim | Results Interim Phase III Data Show Praxbind® (idarucizumab) Reverses Dabigatran (Pradaxa®) in Emergency Situations prnewswire.com ↗ |
| 2015-11-09 | Boehringer Ingelheim | Results Real-World Analysis of More Than 44,000 Patients Reinforces Safety and Effectiveness of Pradaxa® (dabigatran etexilate mesylate) in Routine Clinical Care prnewswire.com ↗
Brigham and Women's Hospital in Boston and Boehringer Ingelheim today announced the results of a new interim analysis from a long-term study evaluating the safety and effectiveness of Pradaxa® (dabigatran etexilate mesylate) relative to warfarin in routine clinical practice. |
| 2015-06-22 | Boehringer Ingelheim | Results Idarucizumab* Reverses the Anticoagulant Effect of Dabigatran Within Minutes in Patient Study prnewswire.com ↗
Results from an interim analysis of the Phase III RE-VERSE AD™ patient study demonstrate that 5 g of idarucizumab* immediately reversed the anticoagulant effect of dabigatran (Pradaxa ® dabigatran etexilate mesylate) in patients requiring urgent anticoagulant reversal. |
| 2015-06-16 | Boehringer Ingelheim | Results Phase I Data Published in The Lancet Show Boehringer Ingelheim's Idarucizumab* Reverses Anticoagulant Effects of Dabigatran prnewswire.com ↗
Results showed that idarucizumab immediately and completely reversed dabigatran-induced anticoagulation and no procoagulant effects were found when measured by a specific assay. |
| 2015-03-16 | Boehringer Ingelheim | Results New Data from Boehringer Ingelheim's GLORIA™-AF Registry Show Non-Valvular Atrial Fibrillation (NVAF) Patients at High Risk of Stroke May Be Undertreated prnewswire.com ↗
Newer drugs known as novel oral anticoagulants (NOACs) accounted for 52.1 percent of anticoagulants prescribed (25.0 percent dabigatran, 20.5 percent rivaroxaban, and 6.6 percent apixaban). |
| 2014-12-08 | Boehringer Ingelheim | Results New Data Show Idarucizumab* Reverses Anticoagulant Effects of Dabigatran (PRADAXA®) in Middle-Aged, Elderly and Renally Impaired Volunteers prnewswire.com ↗
Further, anticoagulation was restored when volunteers were re-dosed with dabigatran 24 hours after idarucizumab was administered. |
| 2014-11-18 | Boehringer Ingelheim | Results New Data Show Idarucizumab* Restores Wound-Site Formation of Fibrin, a Key Component of Blood Clotting, in Healthy Volunteers Given Pradaxa® (dabigatran etexilate mesylate) prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. today announced phase I study sub-analyses showing that its investigational antidote idarucizumab reverses the effects of dabigatran, the active ingredient in Pradaxa® (dabigatran etexilate mesylate), on fibrin formation in healthy volunteers. |
| 2014-11-18 | Boehringer Ingelheim | Results Interim Data Reinforce Safety and Effectiveness of Pradaxa® (dabigatran etexilate mesylate) versus Warfarin in Routine Care of Patients with Non-valvular Atrial Fibrillation prnewswire.com ↗
The data also showed a 23 percent reduction in strokes in patients taking PRADAXA compared to warfarin in this pooled analysis of both databases (HR 0.77, CI 0.54-1.09, 62 vs. 69 events). |
| 2014-11-03 | Boehringer Ingelheim | Results FDA Study of Medicare Patients Reaffirms Safety and Efficacy Profile of Pradaxa® (dabigatran etexilate mesylate) for NVAF prnewswire.com ↗
The study found no difference in major bleeds or myocardial infarction with PRADAXA compared to warfarin. |
| 2014-08-25 | Boehringer Ingelheim | Results Pradaxa® (dabigatran etexilate mesylate) Data to be Presented at European Society of Cardiology Congress 2014 prnewswire.com ↗
Dabigatran-induced anticoagulant and bleeding effects can be reversed with both prothrombin complex concentrates and a specific antidote |
| 2014-04-07 | Boehringer Ingelheim | Regulatory FDA Approves Pradaxa® (dabigatran etexilate mesylate) for Treatment and Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism prnewswire.com ↗
This new FDA approval expands dabigatran's indications to include treatment and the reduction of the risk of recurrence of DVT and PE. |
| 2013-12-17 | Boehringer Ingelheim | Results Phase III Study of Dabigatran Etexilate Mesylate Met Primary Endpoint for Six-Month Treatment of Deep Vein Thrombosis (DVT) and/or Pulmonary Embolism (PE) prnewswire.com ↗
In this Phase III study, published online in the American Heart Association's journal Circulation, dabigatran met the primary endpoint of non-inferiority to warfarin for recurrent, symptomatic, objectively-confirmed DVT and/or PE and related deaths during six months of treatment. |
| 2013-11-18 | Boehringer Ingelheim | Results Long-Term Data Presented at American Heart Association Scientific Sessions Reinforce Safety Profile of Pradaxa® (dabigatran etexilate mesylate) prnewswire.com ↗
This new analysis showed that the rates of stroke or systemic embolism for dabigatran 150 mg BID and 110 mg BID were 1.25 percent and 1.54 percent per year, respectively. |
| 2013-11-18 | Boehringer Ingelheim | Results Data from First Phase I Study of Antidote for Pradaxa® (dabigatran etexilate mesylate) Presented at American Heart Association Scientific Sessions prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. today announced results showing that its investigational fully humanized antibody fragment (Fab) rapidly reversed the anticoagulation effect of dabigatran in healthy male volunteers. |
| 2013-10-02 | Boehringer Ingelheim | Results New Pooled Analysis Reports Pradaxa® (dabigatran etexilate mesylate) May Be Associated With Better Patient Outcomes After a Major Bleeding Event Compared to Warfarin prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. today announced results from a retrospective analysis comparing clinical management and patient outcomes following a major bleeding event during treatment with dabigatran or warfarin. |
| 2013-06-14 | Boehringer Ingelheim | Results New Long-Term Data Published in Circulation Reinforce Safety Profile of Pradaxa® (dabigatran etexilate mesylate) prnewswire.com ↗
Rates of major bleeding, the primary endpoint, were 3.74 percent (n=238) per year with PRADAXA 150mg and 2.99 percent (n=190) per year with dabigatran 110mg (HR 1.26, 95% CI: 1.04-1.53). |
| 2013-02-20 | Boehringer Ingelheim | Results New Study Results Published in the New England Journal of Medicine Show Dabigatran Etexilate Mesylate Reduces the Risk of Recurrent Venous Thromboembolism prnewswire.com ↗
RE-MEDY demonstrated that treatment with dabigatran 150 mg twice daily was non-inferior to warfarin (p=0.01) in preventing recurrent VTE, including VTE-related death. |
| 2012-12-08 | Boehringer Ingelheim | Results New Sub-Analyses Report Pradaxa® (dabigatran etexilate mesylate) May Be Associated With Better Patient Outcomes After a Major Bleeding Event Compared to Warfarin prnewswire.com ↗
These findings from the RE-LY® trial and four other Phase III trials report outcomes after a major bleed on dabigatran, despite the lack of a specific reversal agent, may be better than after a warfarin-associated bleed. |
| 2012-11-07 | Boehringer Ingelheim | Results Interim Results from RELY-ABLE®, the RE-LY® Extension Study, Provide Additional Clinical Evidence for the Safety of Pradaxa® (dabigatran etexilate mesylate) prnewswire.com ↗
There were no new safety findings identified in the interim study results. |
| 2012-11-04 | Boehringer Ingelheim | Results RE-LY® Sub-Analysis Suggests Similar Safety and Efficacy With Pradaxa® (dabigatran etexilate mesylate) Versus Warfarin in NVAF Patients With and Without Diabetes prnewswire.com ↗
These results are encouraging, as they indicate PRADAXA 150mg twice daily is effective in this higher risk NVAF patient population, a group in need of effective treatments," said Paul Reilly , PhD, clinical program director, Boehringer Ingelheim Pharmaceuticals, Inc. |
| 2012-06-06 | Boehringer Ingelheim | Regulatory Pradaxa® (dabigatran etexilate mesylate) U.S. Label Now Affirms Superior Reduction in Ischemic and Hemorrhagic Stroke Versus Warfarin in Patients with Non-Valvular Atrial Fibrillation prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the Pradaxa® (dabigatran etexilate mesylate) capsules prescribing information has been updated to affirm that "PRADAXA 150mg twice daily was superior in reducing ischemic and hemorrhagic strokes relative to warfarin." |
| 2012-04-18 | Boehringer Ingelheim | Results New Sub-Analysis Evaluates Outcomes Associated with Lower Intracranial Hemorrhage Rates for Pradaxa® (dabigatran etexilate mesylate) Versus Warfarin in the RE-LY® Trial prnewswire.com ↗
A new retrospective sub-analysis of the 18,113 patient RE-LY® trial showed lower rates of intracranial hemorrhage (ICH), including both fatal and traumatic ICH, for Pradaxa® (dabigatran etexilate mesylate) capsules 150mg taken twice daily compared with warfarin. |
| 2011-01-05 | Boehringer Ingelheim | Results New Sub-Analysis of RE-LY Trial Examines Pradaxa in Patients with Atrial Fibrillation Undergoing Cardioversion prnewswire.com ↗
Similarly, major bleeding within 30 days of cardioversion was infrequent and comparable between treatment groups (1.7%, 0.6% and 0.6%, respectively). |
All press releases naming this drug 91 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 114 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | dabigatran | “For direct oral anticoagulant users this will be in general 48 hours before the procedure, except for Dabigatran users with renal insufficiency: with estimated glomerular...” NCT04437303 ↗109“Patients will be chronically treated with NOAC including apixaban (2x5 mg or 2x2.5 mg depending on the dose reduction regimen) or dabigatran (2x150 mg or 2x110 mg depending on...” NCT06212674 ↗ “DOACs (eg Apixaban, dabigatran, edoxaban and rivaroxaban) are recommended by The National Institute for Health and Care Excellence (NICE) for those over 65 with AF and a...” NCT06322953 ↗ “NOAC includes dabigatran 150mg or 110mg twice daily, rivaroxaban 15mg daily with the reduced dose of 10mg daily, apixaban 5mg twice daily with the reduced dose of 2.5mg twice...” NCT01962545 ↗ “edoxaban 60 mg daily (dose reduction to 30 mg, if applicable), apixaban 5 mg twice daily (dose reduction to 2.5 mg, if applicable), dabigatran 110 mg twice daily, or...” NCT03968393 ↗ “For those randomized to group B (NOAC group), patients will be treated using a registered NOAC (rivaroxaban, apixaban or dabigatran, but preferentionally apixaban) at the dose...” NCT02426944 ↗ “Non-vitamin K antagonist oral anticoagulant therapy (e.g., apixaban, rivaroxaban, dabigatran, or edoxaban) administered according to approved labeling and guideline-recommended dosing.” NCT07497893 ↗ “Participants in the continuation arm will receive oral anticoagulant drugs such as dabigatran, rivaroxaban, apixaban, warfarin, etc. tailored to their specific risk profiles.” NCT06615596 ↗ “Dabigatran (Pradaxa®) is indicated for the prevention of thrombotic events (for example stroke or heart attack) in people with atrial fibrillation.” NCT02606552 ↗ “DOA study medications (Apixaban, Rivaroxaban and Dabigatran) will be prescribed and supplied in the usual setting of patient care” NCT05825573 ↗ “Administration of approved DOACs (e.g., apixaban, rivaroxaban, edoxaban, or dabigatran) at standard stroke prevention dosages.” NCT07609654 ↗ |
| Known as | BIBR 953 ZW | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02171442 ↗ |
| Known as | Dabigatran (Pradaxa) | “Dabigatran (Pradaxa)” NCT03465735 ↗ |
| Known as | dabigatran etexilate | “Dabigatran etexilate is a novel oral anticoagulant.” NCT02524210 ↗1“multiple doses of Dabigatran Etexilate (150 mg Bid)” NCT02171598 ↗ |
| Known as | dabigatran etexilate mesylate | “dabigatran etexilate mesylate (EM) absorption” PMID 27717999 ↗ Oct 2016 |
| Known as | Dabigatrana | “Dabigatrana 110 or 150 mg tablet and Apixaban 2,5 or 5mg tablet by mouth, every 12 hours, continuous use.” NCT03181386 ↗ |
| Known as | Dabigatranetexilat | “Direct oral anticoagulants (DOAC) treatment will encompass any of the approved drugs: Rivaroxaban, Edoxaban, Dabigatranetexilat, and Apixaban (Table 1).” NCT06449469 ↗ |
| Known as | Pradaxa | “Market approved oral anticoagulation (OAC), such as warfarin (Coumadin), dabigatran (Pradaxa), rivaroxaban (Xarelto), apixiban (Eliquis), edoxaban (Savaysa), or betrixaban (Bevyxxa)” NCT04684212 ↗4“Dabigatran (Pradaxa®) is indicated for the prevention of thrombotic events (for example stroke or heart attack) in people with atrial fibrillation.” NCT02606552 ↗ “Early treatment with Rivaroxaban (Xarelto®), Dabigatran (Pradaxa®), Apixaban (Eliquis®) or Edoxaban (Lixiana®)” NCT03148457 ↗ “novel oral anticoagulant includes 'dabigatran,Pradaxa®', 'rivaroxaban,Xarelto®', and 'apixaban, Eliquis®'.” NCT02504177 ↗ “Dabigatran (Pradaxa)75 mg” NCT01385683 ↗ |
| Known as | Pradaxa is the brand name for dabigatran | “Pradaxa is the brand name for dabigatran” NCT01478282 ↗ |
| Action | Inhibit | “Dabigatran is a new oral direct thrombin inhibitor.” PMID 19717844 ↗ Aug 2009 |
| Route | Oral | “Dabigatran is a new oral direct thrombin inhibitor.” PMID 19717844 ↗ Aug 2009 |
| Target | F2 | “the direct thrombin inhibitor dabigatran” NCT01812200 ↗ |