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Etofen (ETOFENAMATE)

Phase 2 active Small molecule

Etofen (generic name: ETOFENAMATE) is a etofenamate drug. It is currently in Phase 2 development for Osteoarthritis.

Etofenamate works by blocking the production of prostaglandins, which are chemicals that cause pain and inflammation.

Etofenamate is a small molecule drug in the etofenamate class, used to treat osteoarthritis. Its exact target is unknown, but it is believed to work by inhibiting the production of prostaglandins, which are chemicals that cause pain and inflammation. Etofenamate is not currently listed as an off-patent medication, but its commercial status is unclear. As a result, its availability and pricing may vary. Further research is needed to fully understand its pharmacokinetics and safety profile.

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 nameETOFENAMATE
Drug classetofenamate
ModalitySmall molecule
Therapeutic areaImmunology
PhasePhase 2

Mechanism of action

Imagine your body has a factory that produces chemicals called prostaglandins, which are like messengers that tell your brain that you're in pain. Etofenamate is like a key that locks the factory door, stopping the production of these pain-causing chemicals. This helps to reduce pain and inflammation in people with osteoarthritis.

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Etofen

What is Etofen?

Etofen (ETOFENAMATE) is a etofenamate drug, indicated for Osteoarthritis.

How does Etofen work?

Etofenamate works by blocking the production of prostaglandins, which are chemicals that cause pain and inflammation.

What is Etofen used for?

Etofen is indicated for Osteoarthritis.

What is the generic name of Etofen?

ETOFENAMATE is the generic (nonproprietary) name of Etofen.

What drug class is Etofen in?

Etofen belongs to the etofenamate class. See all etofenamate drugs at /class/etofenamate.

What development phase is Etofen in?

Etofen is in Phase 2.

Related

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