Last reviewed · How we verify
TAS-205
TAS-205 is a Small molecule drug developed by Taiho Pharmaceutical Co., Ltd.. It is currently in Phase 2 development.
TAS-205 is a small molecule that acts as an estrogen receptor alpha antagonist. It is being studied in a Phase I clinical trial for the treatment of Duchenne Muscular Dystrophy.
-
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 | TAS-205 |
|---|---|
| Sponsor | Taiho Pharmaceutical Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Phase 3 Study of TAS-205 in Patients With Duchenne Muscular Dystrophy(REACH-DMD) (PHASE3)
- Mass Balance Study of [14C] TAS-205 in Healthy Volunteers (PHASE1)
- A Study of TAS-205 for Duchenne Muscular Dystrophy (PHASE1)
- A Phase IIa Study of TAS-205 for Duchenne Muscular Dystrophy (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:
- TAS-205 CI brief — competitive landscape report
- TAS-205 updates RSS · CI watch RSS
- Taiho Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about TAS-205
What is TAS-205?
Who makes TAS-205?
What development phase is TAS-205 in?
Related
- Manufacturer: Taiho Pharmaceutical Co., Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing