Last reviewed 2026-05-26 · How we verify

Chlorphenoxamide (CLEFAMIDE)

Phase 2 active Small molecule ✓ Verified May 2026

Chlorphenoxamide (generic name: CLEFAMIDE) is a clefamide drug. It is currently in Phase 2 development.

Clefamide is believed to work by modulating certain cellular processes.

Chlorphenoxamide is a small molecule with synonyms including Clefamida, Clefamide, and Clefamide.

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	CLEFAMIDE
Drug class	clefamide
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Think of it like a key that unlocks a specific door in a cell. When this door is unlocked, it allows the cell to function differently, which can help treat certain conditions. However, the exact details of how this works are still unknown.

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:

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

Frequently asked questions about Chlorphenoxamide

What is Chlorphenoxamide?

Chlorphenoxamide (CLEFAMIDE) is a clefamide drug.

How does Chlorphenoxamide work?

Clefamide is believed to work by modulating certain cellular processes.

What is the generic name of Chlorphenoxamide?

CLEFAMIDE is the generic (nonproprietary) name of Chlorphenoxamide.

What drug class is Chlorphenoxamide in?

Chlorphenoxamide belongs to the clefamide class. See all clefamide drugs at /class/clefamide.

What development phase is Chlorphenoxamide in?

Chlorphenoxamide is in Phase 2.

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

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