Last reviewed · How we verify
Prostavasin
Prostavasin is a Small molecule drug developed by Hannover Medical School. It is currently in Phase 2 development for Aorta Dextratransposition with Intact Ventricular Septum, Coarctation of aorta, Congenital Heart Defect Requiring Open Patent Ductus Arteriosus. Also known as: Aprostadil.
Prostavasin is a compound that has been studied in various clinical trials for conditions such as Diabetic Foot Ulcer, Inflammatory Bowel Disease, Chronic Idiopathic Constipation, Dental Pain, and Congestive Heart Failure. It has been investigated as part of continuous intra-femoral thrombolysis, conventional therapy, and in combination with Lubiprostone, but its exact mechanism of action is not specified in the available information.
-
Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Prostavasin |
|---|---|
| Also known as | Aprostadil |
| Sponsor | Hannover Medical School |
| Target | Cation channel sperm-associated protein 1, Cation channel sperm-associated protein 2, Cation channel sperm-associated protein 3 |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 2 |
Approved indications
- Aorta Dextratransposition with Intact Ventricular Septum
- Coarctation of aorta
- Congenital Heart Defect Requiring Open Patent Ductus Arteriosus
- Congenital atresia of the pulmonary valve
- Congenital atresia of tricuspid valve
- Ebstein's anomaly of tricuspid valve
- Impotence
- Pulmonary artery stenosis
- Tetralogy of Fallot
Common side effects
Key clinical trials
- The Anifrolumab PRIM Program
- Creation of a Scale for Assessing Pain and Discomfort in Extremely Premature Infants (EDEX) Hospitalised in Neonatal Intensive Care, Inspired by the Early Infant Pain and Discomfort Scale (EDIN)
- Feasibility Evaluation of the Muse Magnetic Resonance Guided Focused Ultrasound System (EARLY_PHASE1)
- Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users
- Continuous Music and Sports Training for Children (NA)
- Laminaria Japonicum Followed by Misoprostol Versus Misoprostol Alone for Mid-Trimester Abortion Induction in Scarred Uterus (PHASE4)
- Safety and Outcomes of MUSE Stem Cell Therapy in Individuals With Traumatic Brain Injury
- Mindfulness-Based Interventions for OCD (NA)
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:
- Prostavasin CI brief — competitive landscape report
- Prostavasin updates RSS · CI watch RSS
- Hannover Medical School portfolio CI
Frequently asked questions about Prostavasin
What is Prostavasin?
What is Prostavasin used for?
Who makes Prostavasin?
Is Prostavasin also known as anything else?
What development phase is Prostavasin in?
What does Prostavasin target?
Related
- Target: All drugs targeting Cation channel sperm-associated protein 1, Cation channel sperm-associated protein 2, Cation channel sperm-associated protein 3
- Manufacturer: Hannover Medical School — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Aorta Dextratransposition with Intact Ventricular Septum
- Indication: Drugs for Coarctation of aorta
- Indication: Drugs for Congenital Heart Defect Requiring Open Patent Ductus Arteriosus
- Also known as: Aprostadil
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing