Last reviewed · How we verify
Fadanafil
Fadanafil is a Small molecule drug developed by Sihuan Pharmaceutical Holdings Group Ltd.. It is currently in Phase 1 development. Also known as: 5849.
-
Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Fadanafil |
|---|---|
| Also known as | 5849 |
| Sponsor | Sihuan Pharmaceutical Holdings Group Ltd. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Evaluate the Effects of Food on the Pharmacokinetics of Fadanafil in Healthy Subjects (PHASE1)
- Evaluate Safety, Tolerability and Pharmacokinetics of Fadanafil （XZP-5849）in Chinese Healthy Adult Male Subjects (PHASE1)
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:
- Fadanafil CI brief — competitive landscape report
- Fadanafil updates RSS · CI watch RSS
- Sihuan Pharmaceutical Holdings Group Ltd. portfolio CI
Frequently asked questions about Fadanafil
What is Fadanafil?
Who makes Fadanafil?
Is Fadanafil also known as anything else?
What development phase is Fadanafil in?
Related
- Manufacturer: Sihuan Pharmaceutical Holdings Group Ltd. — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: 5849
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing