Last reviewed 2026-05-19 · How we verify

Cindomet (CINMETACIN)

Phase 2 active Small molecule ✓ Verified May 2026

Cindomet (generic name: CINMETACIN) is a cinmetacin drug. It is currently in Phase 2 development.

Cinmetacin works by blocking the production of prostaglandins, hormone-like substances that cause pain and inflammation.

Cindomet is a small molecule with synonyms including Cindomet, Cinmetacin, Cinmetacina, Cinmetacine, and Indolacine.

Likelihood of approval

15.3% 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).

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	CINMETACIN
Drug class	cinmetacin
Modality	Small molecule
Therapeutic area	Pain
Phase	Phase 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 or inflamed. Cinmetacin is like a factory worker who stops the production of these messengers, reducing the pain and inflammation. This helps to relieve symptoms of conditions like arthritis or other inflammatory diseases.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Cindomet CI brief — competitive landscape report
Cindomet updates RSS · CI watch RSS

Frequently asked questions about Cindomet

What is Cindomet?

Cindomet (CINMETACIN) is a cinmetacin drug.

How does Cindomet work?

Cinmetacin works by blocking the production of prostaglandins, hormone-like substances that cause pain and inflammation.

What is the generic name of Cindomet?

CINMETACIN is the generic (nonproprietary) name of Cindomet.

What drug class is Cindomet in?

Cindomet belongs to the cinmetacin class. See all cinmetacin drugs at /class/cinmetacin.

What development phase is Cindomet in?

Cindomet is in Phase 2.

Drug class: All cinmetacin drugs
Therapeutic area: All drugs in Pain

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