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Fibrocaps
Fibrocaps is a Biologic drug developed by Mallinckrodt. It is currently in Phase 3 development. Also known as: PRO-0601, Fibrin sealant, Raplixa.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Fibrocaps |
|---|---|
| Also known as | PRO-0601, Fibrin sealant, Raplixa |
| Sponsor | Mallinckrodt |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
- Procedural Pain
- Nausea
- Constipation
- Incision site pain
- Insomnia
- Hypotension
- Pyrexia
- Anaemia
- Pruritus
- Vomiting
- Hypertension
- Procedural nausea
Key clinical trials
- Topical Raplixa for Surgical Bleeding in Children (PHASE2)
- A Study of Fibrocaps™ in Surgical Bleeding (PHASE3)
- U.S. Study of Fibrocaps in Surgical Hemostasis (NA)
- A Safety and Efficacy Study Comparing Fibrocaps and Tachosil in Hepatic Surgery (PHASE3)
- A Study of Fibrocaps in Liver Surgery in the Netherlands (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Fibrocaps CI brief — competitive landscape report
- Fibrocaps updates RSS · CI watch RSS
- Mallinckrodt portfolio CI
Frequently asked questions about Fibrocaps
What is Fibrocaps?
Who makes Fibrocaps?
Is Fibrocaps also known as anything else?
What development phase is Fibrocaps in?
What are the side effects of Fibrocaps?
Related
- Manufacturer: Mallinckrodt — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: PRO-0601, Fibrin sealant, Raplixa
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing