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Phenoptin
Phenoptin is a Small molecule drug developed by BioMarin Pharmaceutical. It is currently in Phase 2 development.
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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).
| 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 | Phenoptin |
|---|---|
| Sponsor | BioMarin Pharmaceutical |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Evaluation of BH4 Responsiveness in Our PKU Patients (PHASE1)
- Exercise and NO in HFrEF (EARLY_PHASE1)
- Rhode Island Diastolic Dysfunction - Heart Failure (NA)
- Novel Approaches for Improving Vascular Function in Veterans With HFpEF (PHASE1)
- Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects (PHASE1)
- Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects Under Fed Conditions (PHASE1)
- The Effects of ATLAS Therapy on Nitric Oxide Bioavailability in Patients With Intermittent Claudication (PHASE1)
- Study of Kuvan Treatment in Adults With GTPCH Deficiency (PHASE1, 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:
- Phenoptin CI brief — competitive landscape report
- Phenoptin updates RSS · CI watch RSS
- BioMarin Pharmaceutical portfolio CI
Frequently asked questions about Phenoptin
What is Phenoptin?
Who makes Phenoptin?
What development phase is Phenoptin in?
Related
- Manufacturer: BioMarin Pharmaceutical — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing