Last reviewed 2026-05-20 · How we verify

Deflamene (FORMOCORTAL)

Phase 2 active Small molecule ✓ Verified May 2026

Deflamene (generic name: FORMOCORTAL) is a formocortal drug. It is currently in Phase 2 development.

Deflamene works by modulating the body's inflammatory response.

Deflamene is a small molecule with the following synonyms: DEFLAMENE, FLUDERMA, FORMOCORTAL.

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	FORMOCORTAL
Drug class	formocortal
Modality	Small molecule
Therapeutic area	Pain
Phase	Phase 2

Mechanism of action

Think of inflammation like a fire in your body. Deflamene helps to calm down the fire by reducing the production of chemicals that make it worse. This can help to reduce pain, swelling, and other symptoms associated with inflammation.

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:

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

Frequently asked questions about Deflamene

What is Deflamene?

Deflamene (FORMOCORTAL) is a formocortal drug.

How does Deflamene work?

Deflamene works by modulating the body's inflammatory response.

What is the generic name of Deflamene?

FORMOCORTAL is the generic (nonproprietary) name of Deflamene.

What drug class is Deflamene in?

Deflamene belongs to the formocortal class. See all formocortal drugs at /class/formocortal.

What development phase is Deflamene in?

Deflamene is in Phase 2.

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

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