Summary
Damoctocog Alfa Pegol has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Haemophilia A / B would be drug repurposing rather than first-in-human development. This does not mean it is approved for Haemophilia A / B. ClinicalTrials.gov lists 8 registered trials linking Damoctocog Alfa Pegol to Haemophilia A / B: 1 is currently recruiting; 4 are active or not yet recruiting; 2 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT04085458). The largest enrolment is 371 participants (NCT03932201). Registration activity spans 2019 to 2026. The literature layer holds 2 publications for this pair: 2 clinical trial publications. Publication years run from 2020 to 2026. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
The RepurpOS disease-intelligence file for Hemophilia ranks 50 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: No spontaneous remission; lifelong clotting factor deficiency; joint damage progressive with each bleed without treatment; with prophylaxis, normal lifespan achievable.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 46.0 (trials 22.0, literature 4.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 4 active / not yet recruiting, 2 completed, 1 other |
| Linked publications | 2 (2 clinical trial publications) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | F8 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT04085458 | Study to Gain More Information on How Safe and Effective Jivi Works in Patients With Severe Hemophilia A (Post-marketing Investigation) 2019 | completed | Phase 4 | 32 |
| NCT04015492 | Study to Compare How the Body Distributes and Excretes the Drugs Jivi (BAY 94-9027) and Adynovi in Patients With Severe Hemophilia A (Bleeding Disorder Resulting From a Lack of Blood Clotting Factor VIII) 2019 | completed | Phase 1 | 18 |
| NCT04461639 | Study to Learn More About the Safety of Drug Jivi Over a Long Period of Time in Previously Treated Patients With Hemophilia A (Bleeding Disorder Resulting From a Lack of FVIII) Who Are Receiving Jivi Regularly at Their Treating Doctors to Prevent Bleeding 2021 | active, not recruiting | Not applicable | 62 |
| NCT05643560 | An Observational Study Called JOIHA to Learn More About How Well the Treatment With Jivi Works to Prevent Problems With Joints in Adults With Hemophilia A. 2022 | active, not recruiting | Not applicable | 33 |
| NCT03932201 | Evaluating Effectiveness and Long Term Safety of Damoctocog Alfa Pegol in Patients, Who Have Been Diagnosed With Hemophilia A 2019 | active, not recruiting | Not applicable | 371 |
| NCT07088458 | An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A 2026 | not yet recruiting | Not applicable | 40 |
| NCT06222697 | A Study to Learn More About the Safety of Damoctocog-alfa-pegol When Used in Routine Medical Care in Korean Participants With Hemophilia A 2024 | recruiting | Not applicable | 20 |
| NCT05395858 | A Study to Learn More About Treatment With Damoctocog Alfa Pegol, How it is Used in Every Day Practice ("Real-World"), and How Satisfied People Who Receive Damoctocog Alfa Pegol Are in United States (US) Hemophilia Treatment Centers 2023 | terminated | Not applicable | 14 |
Published literature
- Clinical trial publication A New Risk-Based Scoring Approach to Individualize Prophylaxis in Patients with Hemophilia A: Results from the PREDICT StudyQuon DV, Escobar M, Boggio L et al. · Advances in therapy · 2026 · PMID 41886249
- Clinical trial publication Direct comparison of two extended half-life PEGylated recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia ASolms A, Shah A, Berntorp E et al. · Annals of hematology · 2020 · PMID 32974838
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target F8. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Damoctocog Alfa Pegol approved for Haemophilia A / B?
Damoctocog Alfa Pegol has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Haemophilia A / B would be drug repurposing rather than first-in-human development. This does not mean it is approved for Haemophilia A / B. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Damoctocog Alfa Pegol in clinical trials for Haemophilia A / B?
ClinicalTrials.gov lists 8 registered trials linking Damoctocog Alfa Pegol to Haemophilia A / B: 1 is currently recruiting; 4 are active or not yet recruiting; 2 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT04085458). The largest enrolment is 371 participants (NCT03932201). Registration activity spans 2019 to 2026.
What does the evidence show for Damoctocog Alfa Pegol in Haemophilia A / B?
Damoctocog Alfa Pegol has 2 completed trials and 2 linked publications for Haemophilia A / B. Completed trials may or may not have posted results; follow the NCT links to check. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target F8. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-06. Page built 2026-10-07.