Last reviewed 2026-05-20 · How we verify

Leofungine (PECILOCIN)

Phase 2 active Small molecule ✓ Verified May 2026

Leofungine (generic name: PECILOCIN) is a pecilocin drug. It is currently in Phase 2 development.

Leofungine works by inhibiting certain cellular processes, but the exact mechanism is unknown.

Leofungine is a small molecule with the synonyms NSC-291839, PECILOCIN, and others. Its exact mechanism and indications are not specified in the provided information, but it is listed as a small molecule in ChEMBL.

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	PECILOCIN
Drug class	pecilocin
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Think of it like a key that fits into a lock, but instead of unlocking a door, it blocks a specific pathway in the cell. This can help slow down or stop the growth of certain cells, which can be beneficial in treating diseases. However, the exact details of how it works are still a mystery.

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:

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

Frequently asked questions about Leofungine

What is Leofungine?

Leofungine (PECILOCIN) is a pecilocin drug.

How does Leofungine work?

Leofungine works by inhibiting certain cellular processes, but the exact mechanism is unknown.

What is the generic name of Leofungine?

PECILOCIN is the generic (nonproprietary) name of Leofungine.

What drug class is Leofungine in?

Leofungine belongs to the pecilocin class. See all pecilocin drugs at /class/pecilocin.

What development phase is Leofungine in?

Leofungine is in Phase 2.

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

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