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Difenan (DIPHENAN)
Difenan (generic name: DIPHENAN) is a drug. It is currently in Phase 2 development.
Difenan is a small molecule that works by binding to a specific target in the body to produce its therapeutic effect.
Difenan (DIPHENAN) is a small molecule drug with unknown target and drug class. Its commercial status is unclear, and it is not known if it is FDA approved or off-patent. The approved indications for Difenan are also unknown. Further information on its pharmacokinetics, such as half-life and bioavailability, is not available. As a result, key safety considerations and generic manufacturers are also unknown.
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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 | DIPHENAN |
|---|---|
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Mechanism of action
Imagine Difenan as a key that fits into a lock in the body. When it binds to its target, it helps to turn off or turn on certain processes that are involved in the disease it's meant to treat. This can help to restore balance and reduce symptoms.
Approved indications
Common side effects
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Difenan CI brief — competitive landscape report
- Difenan updates RSS · CI watch RSS
Frequently asked questions about Difenan
What is Difenan?
How does Difenan work?
What is the generic name of Difenan?
What development phase is Difenan in?
Related
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing