Drugs / Marstacimab
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed hemophilia B leyden 2 milestones | |||||
| Filed | EU (EMA) | — | hemophilia B leyden | 2023-12-11 | “The European marketing authorization application (MAA) for marstacimab also passed validation and is currently under review by the European Medicines Agency (EMA).” pfizer.com ↗ |
| Filed | US (FDA) | — | hemophilia B leyden | 2023-12-11 | “FDA has accepted the company’s Biologics License Application (BLA) for its anti-tissue factor pathway inhibitor (anti-TFPI) candidate marstacimab” pfizer.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Hympavzi | — | 2024-11-18 | europa.eu ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT06703606 | May 2025 → May 2027 expected | severe hemophilia A | Pfizer | Recruiting | No outcome recorded |
| Phase 1 | NCT04878731 | Apr → Aug 2021 | hemophilia | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT04832139 | Mar → Nov 2021 | — | Pfizer | Terminated | No outcome recorded |
| Phase 1 | NCT02531815 | Aug 2015 → Jul 2016 | — | Pfizer | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT03363321 | May 2018 → Aug 2020 | hemophilia | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT02974855 | Mar 2017 → Dec 2018 | hemophilia | Pfizer | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT05611801 | Dec 2022 → Sep 2028 expected | hemophilia A, hemophilia B | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT05145127 | Nov 2021 → Jul 2030 expected | hemophilia A, hemophilia B | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT03938792 | Mar 2020 → Apr 2025 | hemophilia A, hemophilia B | Pfizer | Completed | Met primary |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-06-08 | Pfizer | Regulatory U.S. FDA Approves Pfizer’s HYMPAVZI for the Treatment of Two Additional Hemophilia A or B Patient Populations with Significant Medical Need pfizer.com ↗
Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for HYMPAVZI ® (marstacimab-hncq) to include the treatment of patients with hemophilia A or B 12 years and older with inhibitors and pediatric patients (ages 6 to 11 years) with or without inhibitors. |
| 2026-05-13 | Pfizer | Regulatory European Commission Approves Pfizer’s HYMPAVZI for the Treatment of Adults and Adolescents with Hemophilia A or B With Inhibitors pfizer.com ↗
Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization to expand the approved indication for HYMPAVZI ® (marstacimab) to include patients 12 years of age and older weighing at least 35 kg with hemophilia A (congenital factor VIII [FVIII] deficiency) with FVIII inhibitors or hemophilia B (congenital factor IX [FIX] deficiency) with FIX inhibitors. |
| 2026-02-06 | Pfizer | Regulatory FDA Grants Priority Review for HYMPAVZI® (marstacimab) sBLA for the Treatment of Two Hemophilia A or B Patient Populations with Significant Medical Need pfizer.com ↗
The FDA has set a Prescription Drug User Fee Act (PDUFA) action date in the second quarter of 2026. |
| 2025-12-06 | Pfizer | Results HYMPAVZI® (marstacimab) Reduced Bleeds by 93% Compared to On-Demand Treatment in Adults and Adolescents with Hemophilia A or B with Inhibitors pfizer.com ↗
Pfizer Inc. (NYSE: PFE) today presented results from the Phase 3 BASIS study ( NCT03938792 ) evaluating HYMPAVZI ® (marstacimab) for adults and adolescents living with hemophilia A or B with inhibitors. |
| 2025-06-26 | Pfizer | Results Pfizer Announces Positive Topline Phase 3 Results for HYMPAVZI™ in Hemophilia A or B with Inhibitors pfizer.com ↗
Pfizer Inc. (NYSE: PFE) today announced positive topline results from the Phase 3 BASIS study ( NCT03938792 ) evaluating HYMPAVZI™ (marstacimab) for adults and adolescents living with hemophilia A or B with inhibitors. |
| 2024-11-20 | Pfizer | Regulatory European Commission Approves Pfizer’s HYMPAVZI™ (marstacimab) for the Treatment of Adults and Adolescents with Severe Hemophilia A or B Without Inhibitors pfizer.com ↗
Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has granted marketing authorization for HYMPAVZI™ (marstacimab) for the routine prophylaxis of bleeding episodes in patients 12 years of age and older weighing at least 35 kg with severe hemophilia A (congenital factor VIII [FVIII] deficiency, FVIII <1%) without FVIII inhibitors or severe hemophilia B (congenital factor IX [FIX] deficiency, FIX <1%) without FIX inhibitors. |
| 2024-10-11 | Pfizer | Regulatory U.S. FDA Approves Pfizer’s HYMPAVZI™ (marstacimab-hncq) for the Treatment of Adults and Adolescents with Hemophilia A or B Without Inhibitors pfizer.com ↗
HYMPAVZI is the first and only anti-tissue factor pathway inhibitor (anti-TFPI) approved in the U.S. for the treatment of hemophilia A or B and the first hemophilia medicine approved in the U.S. to be administered via a pre-filled, auto-injector pen. |
| 2023-12-11 | Pfizer | Regulatory FDA and EMA Accept Marstacimab Regulatory Submissions for the Treatment of Hemophilia A and B pfizer.com ↗
The European marketing authorization application (MAA) for marstacimab also passed validation and is currently under review by the European Medicines Agency (EMA). |
| 2023-12-09 | Pfizer | Results Marstacimab Phase 3 Data Presented at ASH 2023 Demonstrate Significant Bleed Reduction in Hemophilia A and B pfizer.com ↗
Marstacimab reduced annualized bleeding rate by 35% and 92% compared to routine prophylaxis and on-demand treatment in patients with hemophilia A and B without inhibitors, respectively |
| 2023-05-30 | Pfizer | Results Pfizer Announces Positive Marstacimab Results from Pivotal Phase 3 Hemophilia A and B Trial pfizer.com ↗
Pfizer Inc. (NYSE: PFE) today announced that the pivotal Phase 3 BASIS clinical trial ( NCT03938792 ) evaluating marstacimab has met its primary endpoints, having demonstrated statically significant and clinically meaningful effects. |
All press releases naming this drug 11 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | marstacimab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05611801 ↗ |
| Known as | Hympavzi | ChEMBL registry synonym — accepted as the source's own label CHEMBL3990039 ↗ |
| Known as | Marstacimab-hncq | ChEMBL registry synonym — accepted as the source's own label CHEMBL3990039 ↗ |
| Known as | PF-06741086 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04878731 ↗ |
| Action | Inhibit | “Tissue factor pathway inhibitor inhibitor” CHEMBL3990039 ↗ |
| Modality | Monoclonal antibody | “an investigational human monoclonal antibody targeting tissue factor pathway inhibitor” PMID 36220152 ↗ Oct 2022 |
| Route | Subcutaneous | “Cohort 1 (subcutaneous [SC]) PF-06741086, Placebo” NCT02531815 ↗ |
| Target | TFPI | “Tissue factor pathway inhibitor inhibitor” CHEMBL3990039 ↗ |