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Amchafibrin
Amchafibrin is a Small molecule drug developed by Fundación Pública Andaluza Progreso y Salud. It is currently in Phase 3 development for Contraception, Endometriosis, Female hypogonadism syndrome.
Amchafibrin is a drug that has been studied in various clinical trials, including those for conditions such as hematological malignancies, COVID-19, pulmonary arterial hypertension, urinary tract infections in children, and hypertension. It is administered as tranexamic acid injection, and its effects on thromboelastography have been studied in a clinical trial.
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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). -
Rare-disease pathway favourability
+5.0pp
Rare-disease drugs benefit from FDA Orphan Drug Act, smaller pivotal trials, and more flexible endpoints. Approval rates run ~5pp above baseline.
| 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 | Amchafibrin |
|---|---|
| Sponsor | Fundación Pública Andaluza Progreso y Salud |
| Target | Plasminogen |
| Modality | Small molecule |
| Therapeutic area | Rare Disease |
| Phase | Phase 3 |
Approved indications
- Contraception
- Endometriosis
- Female hypogonadism syndrome
- Hemorrhaging in Hemophilia
- Menorrhagia
Common side effects
Key clinical trials
- Comparative Evaluation of Topical Metformin and Topical Tranexamic Acid in Melasma (NA)
- Tranexamic Acid for The Treatment of Gastrointestinal Bleeding (NA)
- Hemoglobin Drop and Need for Blood Transfusion in Primary Knee Arthroplasty With or Without Drain Insertion (NA)
- Extended Oral Tranexamic Acid After Primary Total Knee Arthroplasty (NA)
- Prevention of Postpartum Hemorrhage With Tranexamic Acid (PHASE2)
- Effects of Red and Infrared Photobiomodulation in Rhinoplasty at a Single Centre (NA)
- Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial (PHASE3)
- The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies (PHASE3)
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:
- Amchafibrin CI brief — competitive landscape report
- Amchafibrin updates RSS · CI watch RSS
- Fundación Pública Andaluza Progreso y Salud portfolio CI
Frequently asked questions about Amchafibrin
What is Amchafibrin?
What is Amchafibrin used for?
Who makes Amchafibrin?
What development phase is Amchafibrin in?
What does Amchafibrin target?
Related
- Target: All drugs targeting Plasminogen
- Manufacturer: Fundación Pública Andaluza Progreso y Salud — full pipeline
- Therapeutic area: All drugs in Rare Disease
- Indication: Drugs for Contraception
- Indication: Drugs for Endometriosis
- Indication: Drugs for Female hypogonadism syndrome
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing