HEMLIBRA (emicizumab)
Hemlibra is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A. It is approved for use in both adult and pediatric populations, including newborns. The therapy is used for patients with congenital factor VIII deficiency, regardless of whether they have developed factor VIII inhibitors.
How HEMLIBRA Works
Hemlibra is a bispecific antibody directed at factor IXa and factor X. It functions by bridging activated factor IX and factor X together. This action restores the function of missing activated factor VIII, which is necessary for effective hemostasis.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-11-16
- Patent Cliff
- 2032
- Revenue
- $1.4B (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
HEMLIBRA Approval History
What HEMLIBRA Treats
2 indicationsHEMLIBRA is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors
- Hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors
HEMLIBRA Boxed Warning
THROMBOTIC MICROANGIOPATHY AND THROMBOEMBOLISM Cases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of >100 U/kg/24 hours of activated prothrombin complex concentrate was administered for 24 hours or more to patients receiving HEMLIBRA prophylaxis. Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. Discontinue aPCC and suspend dosing of HEMLIBRA if symptoms occur. WARNING: THROMBOTIC MICR...
WARNING: THROMBOTIC MICROANGIOPATHY AND THROMBOEMBOLISM Cases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of >100 U/kg/24 hours of activated prothrombin complex concentrate was administered for 24 hours or more to patients receiving HEMLIBRA prophylaxis. Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. Discontinue aPCC and suspend dosing of HEMLIBRA if symptoms occur. WARNING: THROMBOTIC MICROANGIOPATHY and THROMBOEMBOLISM See full prescribing information for complete boxed warning. Cases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of >100 U/kg/24 hours of activated prothrombin complex concentrate (aPCC) was administered for 24 hours or more to patients receiving HEMLIBRA prophylaxis. Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. Discontinue aPCC and suspend dosing of HEMLIBRA if symptoms occur.
HEMLIBRA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
23 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07416604 ZEBRHA 2 | BO45887 2025-522435-33-00 | Ph 3 | recruiting | A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A |
| NCT04563520 SAFE | STUDY00000804 2025P010684 | Ph 3 | recruiting | SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis |
| NCT05181618 Beyond ABR | MO42623 2020-005092-13, 2023-505747-40-00 | Ph 4 | active not recruiting | A Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis |
| NCT06998524 WILL-EMI | WP45338 2024-515622-80-00 | Ph 3 | recruiting | A Study to Assess the Efficacy and Safety of Emicizumab in Participants With Type 3 Von Willebrand Disease |
| NCT04431726 HAVEN 7 results posted | MO41787 2020-001733-12, 2023-505964-13-00 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Emicizumab in Participants From Birth to 12 Months of Age With Hemophilia A Without Inhibitors |
| NCT04690322 | STU-2020-1378 | Ph 4 | withdrawn | POCUS: Hemostatic Potential and Joint Health in Patients With Severe Hemophilia A on Novel Replacement Therapies |
| NCT05500807 BCDI-XII | BCDI-XII | Ph 1 | recruiting | Emicizumab for Severe Von Willebrand Disease (VWD) and VWD/Hemophilia A |
| NCT03315455 HAVEN 5 results posted | YO39309 | Ph 3 | completed | Efficacy, Safety, and Pharmacokinetic Study of Prophylactic Emicizumab Versus No Prophylaxis in Hemophilia A Participants |
| NCT04158648 HAVEN 6 results posted | BO41423 2019-002179-32, 2023-506610-52-00 | Ph 3 | completed | A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Emicizumab in Participants With Mild or Moderate Hemophilia A Without FVIII Inhibitors |
| NCT05345197 AHAEmi | STUDY00013920 | Ph 2 | active not recruiting | Emicizumab in Patients With Acquired Hemophilia A |
| NCT06145373 | SFY17741 2022-502414-84, U1111-1280-7227 | Ph 4 | recruiting | A Study to Test a Medicine (Fitusiran) for Preventing Bleeds in People With Severe Hemophilia Who Previously Received Preventive Treatment With Emicizumab |
| NCT07158606 UTILITI | PRO00052811 | Ph 4 | not yet recruiting | Understanding Treatment Outcomes and Immunologic Mechanisms in Altuviiio Immune Tolerance Induction |
| NCT03921294 results posted | RO-IIS-2018-10581 | Ph 4 | terminated | HemLibra Prophylaxis in Patients With Hemophilic Pseudotumor |
| NCT04567511 | RO-IIS-2019-20049 | Ph 4 | recruiting | Hemlibra in Mild Hemophilia A |
| NCT04030052 | IRB00111805 | Ph 3 | withdrawn | Emicizumab PUPs and Nuwiq ITI Study |
| NCT04303572 results posted | PRO19070080 H30MC24050 | Ph 3 | terminated | The Hemophilia Inhibitor Eradication Trial |
| NCT03020160 HAVEN 4 results posted | BO39182 2016-001094-33 | Ph 3 | completed | A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Emicizumab Given Every 4 Weeks in Participants With Hemophilia A |
| NCT02847637 HAVEN 3 results posted | BH30071 2016-000072-17 | Ph 3 | completed | A Clinical Trial to Evaluate Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants Without Inhibitors |
| NCT02622321 HAVEN 1 results posted | BH29884 2015-002866-21 | Ph 3 | completed | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants With Inhibitors |
| NCT03191799 STASEY results posted | MO39129 2016-004366-25 | Ph 3 | completed | A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors |
| NCT02795767 HAVEN 2 results posted | BH29992 2016-000073-21 | Ph 3 | completed | A Study of Emicizumab Administered Subcutaneously (SC) in Pediatric Participants With Hemophilia A and Factor VIII (FVIII) Inhibitors |
| NCT03361137 results posted | ML39791 | Ph 4 | terminated | Study of Emicizumab Prophylaxis in Participants With Hemophilia A With or Without Inhibitors Undergoing Minor Surgical Procedures |
| NCT03380780 results posted | YP39308 | Ph 1 | completed | A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Emicizumab in Healthy Chinese Volunteers |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
HEMLIBRA FDA Label Details
Indications & Usage
FDA Label (PDF)HEMLIBRA is indicated for the treatment of Hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors; Hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors.
WARNING: THROMBOTIC MICROANGIOPATHY AND THROMBOEMBOLISM Cases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of >100 U/kg/24 hours of activated prothrombin complex concentrate was administered for 24 hours or more to patients receiving HEMLIBRA ...
Pro Intelligence Preview
Deep insights for HEMLIBRA
Revenue Insights
- • Q4-2025: $1.4B
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • Generic/biosimilar risk
Trial Analysis
- • 23 total trials
- • Stage: Expansion
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment