Drugs / Milvexian
Trials 24
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 119 trials | ||||||
| Phase 1 | NCT05706753 | Jan → Jul 2023 | — | Janssen Pharmaceutica N.V., Belgium | Completed | No outcome recorded |
| Phase 1 | NCT04965389 | Jul → Aug 2021 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04388501 | Jun → Oct 2021 | — | Janssen Pharmaceutica N.V., Belgium | Completed | No outcome recorded |
| Phase 1 | NCT04844424 | Apr 2021 → May 2022 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04569695 | Mar → Dec 2021 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04543383 | Jul 2020 → Jun 2023 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04448964 | Jun → Nov 2020 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04223349 | Jan → Apr 2020 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04206488 | Jan 2020 → Jun 2021 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03698513 | Oct 2018 → Feb 2019 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT02982707 | Mar → Sep 2018 | thrombotic disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03362437 | Nov → Dec 2017 | thrombotic disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03341390 | Oct → Nov 2017 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03196206 | Jul 2017 → Mar 2018 | thrombotic disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03224260 | Jun → Nov 2017 | thrombotic disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT02959060 | Nov → Dec 2016 | thrombotic disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT02902679 | Nov 2016 → Jun 2017 | end stage renal failure, impaired renal function disease, thrombotic disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT02807909 | Jul → Aug 2016 | thrombotic disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT02608970 | Dec 2015 → Jul 2017 | thrombotic disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 22 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT03891524 | Jun 2019 → Apr 2021 | osteoarthritis, knee | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 2 | NCT03766581 | Jan 2019 → Mar 2022 | transient ischemic attack | Bristol-Myers Squibb | Completed | Missed primary |
| Phase 33 trials | ||||||
| Phase 3 | NCT05757869 | Apr 2023 → Dec 2026 expected | atrial fibrillation | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05754957 | Apr 2023 → Feb 2026 | acute coronary syndrome | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT05702034 | Feb 2023 → Oct 2026 expected | ischemic stroke | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT03939702 Comparator | May → Jul 2019 | thrombotic disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/2 | NCT03000673 Comparator | May → Oct 2017 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2025-11-14 | Bristol-Myers Squibb | Results Update on Phase 3 Librexia ACS Trial bms.com ↗
The decision to discontinue the trial follows a preplanned interim analysis by the Independent Data Monitoring Committee (IDMC), which determined the trial is unlikely to meet the primary efficacy endpoint. |
| 2023-05-25 | Janssen Research & Development, LLC | Regulatory Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial Fibrillation jnj.com ↗
All three indications being studied in the Phase 3 Librexia program were granted Fast Track Designation from the FDA. |
| 2023-05-25 | Janssen Research & Development, LLC | Regulatory Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial Fibrillation jnj.com ↗
Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial Fibrillation |
| 2023-05-25 | Bristol-Myers Squibb | Regulatory Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial Fibrillation bms.com ↗
All three indications being studied in the Phase 3 Librexia program were granted Fast Track Designation from the FDA. |
| 2022-08-28 | Bristol-Myers Squibb | Results Late-Breaking Results From Phase 2 AXIOMATIC-SSP Study of Milvexian, an Investigational Oral Factor XIa Inhibitor, Show Favorable Antithrombotic Profile in Combination With Dual Antiplatelet Therapy bms.com ↗
A relative risk reduction of approximately 30% in symptomatic ischemic stroke with milvexian was observed in patients receiving either 25, 50 or 100 mg twice daily compared to placebo. |
| 2021-11-15 | Janssen Research & Development, LLC | Results Late-Breaking Phase 2 Data for Investigational Oral Factor XIa Inhibitor Milvexian Suggest Favorable Antithrombotic Profile Across a Wide Range of Doses jnj.com ↗
At daily doses of at least 100 mg, the rates of VTE with milvexian were significantly lower than with enoxaparin (p≤0.014). |
| 2021-11-15 | Janssen Research & Development, LLC | Results Late-Breaking Phase 2 Data for Investigational Oral Factor XIa Inhibitor Milvexian Suggest Favorable Antithrombotic Profile Across a Wide Range of Doses jnj.com ↗
Milvexian demonstrated efficacy and no increase in bleeding across doses with no major bleeds in the milvexian arms, when compared with enoxaparin, for postoperative venous thromboembolism (VTE) prevention in patients undergoing elective total knee replacement (TKR) surgery |
| 2021-11-15 | Bristol-Myers Squibb | Results Late-Breaking Phase 2 Data for Investigational Oral Factor XIa Inhibitor Milvexian Suggest Favorable Antithrombotic Profile Across a Wide Range of Doses bms.com ↗
Milvexian demonstrated efficacy and no increase in bleeding across doses, with no major bleeds in the milvexian arms, when compared with enoxaparin, for postoperative venous thromboembolism (VTE) prevention in patients undergoing elective total knee replacement (TKR) surgery |
All press releases naming this drug 9 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Milvexian | “Milvexian (BMS-986177/JNJ-70033093) is a potent, oral small molecule that inhibits the active form of factor XI with high affinity and selectivity.” PMID 36564395 ↗ Dec 202210“Single-Dose Pharmacokinetics of Milvexian in Participants with Normal Renal Function and Participants with Moderate or Severe Renal Impairment.” PMID 35906349 ↗ Jul 2022 “A Study to Assess the Absolute Oral Bioavailability of Milvexian Using a 14C-Microtracer and Oral Solution in Healthy Participants” NCT04965389 ↗ “Milvexian (BMS-986177/JNJ-70033093) is a small-molecule, active-site inhibitor of activated Factor XI (FXIa).” PMID 35262846 ↗ Mar 2022 |
| Known as | BMS-986177 | “Milvexian (BMS-986177/JNJ-70033093) is a small-molecule, active-site inhibitor of activated Factor XI (FXIa).” PMID 35262846 ↗ Mar 202212“A Study of JNJ-70033093 (BMS-986177) in Healthy Adult Participants” NCT04223349 ↗ |
| Known as | JNJ-70033093 | “Milvexian (BMS-986177/JNJ-70033093) is a potent, oral small molecule that inhibits the active form of factor XI with high affinity and selectivity.” PMID 36564395 ↗ Dec 20226“Milvexian (BMS-986177/JNJ-70033093) is a small-molecule, active-site inhibitor of activated Factor XI (FXIa).” PMID 35262846 ↗ Mar 2022 |
| Action | Inhibit | “inhibits the active form of factor XI with high affinity and selectivity” PMID 36564395 ↗ Dec 20221“Coagulation factor XI inhibitor” CHEMBL4112929 ↗ |
| Modality | Small molecule | “oral small molecule” PMID 36564395 ↗ Dec 2022 |
| Route | Oral | “An oral dose of BMS-986177 administered in End-stage Renal Dysfunction (ESRD) participants” NCT02902679 ↗ |
| Target | F11 | “Coagulation factor XI inhibitor” CHEMBL4112929 ↗ |