Last reviewed 2026-04-20 · How we verify

Esiclene (FORMEBOLONE)

Phase 2 active Small molecule

Esiclene (generic name: FORMEBOLONE) is a formebolone drug. It is currently in Phase 2 development.

Esiclene works by mimicking the effects of cortisol in the body, but with a modified structure that may reduce side effects.

Esiclene, also known as formebolone, is a small molecule drug in the formebolone class. It was originally developed by, but its current owner is unknown. The exact target of Esiclene is not specified, and it is not FDA-approved for any indications. As a result, there is limited information available on its commercial status, pharmacokinetics, or safety profile. Further research is needed to fully understand Esiclene's properties and potential uses.

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 name	FORMEBOLONE
Drug class	formebolone
Modality	Small molecule
Therapeutic area	Immunology
Phase	Phase 2

Mechanism of action

Imagine your body has a thermostat that regulates inflammation and stress. Esiclene is like a special key that fits into this thermostat, but instead of turning it up or down, it helps the thermostat work more smoothly and efficiently. This can help reduce inflammation and alleviate symptoms associated with certain conditions.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

The Use of Osmotic Laxatives Versus Macrogol for Bowel Preparation in Patients Undergoing Colonoscopy (NA)

Primary sources

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

Source	Used for
ClinicalTrials.gov	Trial 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:

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

Frequently asked questions about Esiclene

What is Esiclene?

Esiclene (FORMEBOLONE) is a formebolone drug.

How does Esiclene work?

Esiclene works by mimicking the effects of cortisol in the body, but with a modified structure that may reduce side effects.

What is the generic name of Esiclene?

FORMEBOLONE is the generic (nonproprietary) name of Esiclene.

What drug class is Esiclene in?

Esiclene belongs to the formebolone class. See all formebolone drugs at /class/formebolone.

What development phase is Esiclene in?

Esiclene is in Phase 2.

Drug class: All formebolone drugs
Therapeutic area: All drugs in Immunology

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