Last reviewed 2026-04-20 · How we verify

Clofenamidum (CLOFENAMIDE)

Phase 2 active Small molecule

Clofenamidum (generic name: CLOFENAMIDE) is a clofenamide drug. It is currently in Phase 2 development.

Clofenamidum is believed to work by modulating the activity of certain enzymes or receptors, although the specific details of its mechanism are not well understood.

Clofenamidum, also known as CLOFENAMIDE, is a small molecule drug in the clofenamide class. Its original development is attributed to an unknown entity, and its current ownership is also unclear. The exact target of Clofenamidum is unknown, and it has not been approved by the FDA for any indications. As a result, there is limited information available on its commercial status, pharmacokinetics, or safety profile. Further research is necessary to determine the potential therapeutic applications and risks associated with Clofenamidum.

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	CLOFENAMIDE
Drug class	clofenamide
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have a complex communication system. Clofenamidum is thought to help regulate this system by influencing the way cells talk to each other. This can potentially help treat various conditions, but more research is needed to confirm its effects.

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:

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

Frequently asked questions about Clofenamidum

What is Clofenamidum?

Clofenamidum (CLOFENAMIDE) is a clofenamide drug.

How does Clofenamidum work?

Clofenamidum is believed to work by modulating the activity of certain enzymes or receptors, although the specific details of its mechanism are not well understood.

What is the generic name of Clofenamidum?

CLOFENAMIDE is the generic (nonproprietary) name of Clofenamidum.

What drug class is Clofenamidum in?

Clofenamidum belongs to the clofenamide class. See all clofenamide drugs at /class/clofenamide.

What development phase is Clofenamidum in?

Clofenamidum is in Phase 2.

Drug class: All clofenamide drugs
Therapeutic area: All drugs in Other

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