Last reviewed 2026-05-30 · How we verify

Etofenamat

Ankara City Hospital Bilkent · Phase 2 active Small molecule Under review

Etofenamat is a Small molecule drug developed by Ankara City Hospital Bilkent. It is currently in Phase 2 development for Osteoarthritis.

Etofenamat is being studied as a treatment for ankle sprains in a clinical trial. It is being compared to diclofenac in this trial, which is also being used to treat ankle sprains.

Likelihood of approval

16.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Etofenamat
Sponsor	Ankara City Hospital Bilkent
Modality	Small molecule
Therapeutic area	Immunology
Phase	Phase 2

Approved indications

Osteoarthritis

Common side effects

No common side effects on file.

Key clinical trials

Topical Treatments for Ankle Sprains

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:

Etofenamat CI brief — competitive landscape report
Etofenamat updates RSS · CI watch RSS
Ankara City Hospital Bilkent portfolio CI

Frequently asked questions about Etofenamat

What is Etofenamat?

Etofenamat is a Small molecule drug developed by Ankara City Hospital Bilkent, indicated for Osteoarthritis.

What is Etofenamat used for?

Etofenamat is indicated for Osteoarthritis.

Who makes Etofenamat?

Etofenamat is developed by Ankara City Hospital Bilkent (see full Ankara City Hospital Bilkent pipeline at /company/ankara-city-hospital-bilkent).

What development phase is Etofenamat in?

Etofenamat is in Phase 2.

Manufacturer: Ankara City Hospital Bilkent — full pipeline
Therapeutic area: All drugs in Immunology
Indication: Drugs for Osteoarthritis

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing