Last reviewed 2026-04-20 · How we verify

Bilevon (NICLOFOLAN)

Phase 2 active Small molecule

Bilevon (generic name: NICLOFOLAN) is a niclofolan drug. It is currently in Phase 2 development.

Bilevon works by inhibiting the ATPase activity of the calcium pump in the plasma membrane of certain cells.

Bilevon, also known as NICLOFOLAN, is a small molecule niclofolan drug. It is a compound originally developed by, but its current owner is unknown. Bilevon's target and exact mechanism of action are also unknown. It is not FDA-approved for any indications, and its commercial status, including patent status and generic availability, is unclear. Key safety considerations for Bilevon are also unknown.

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	NICLOFOLAN
Drug class	niclofolan
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Think of it like a lock and key. Bilevon is a key that fits into a specific lock on the surface of certain cells, preventing them from pumping out calcium ions. This can affect how these cells function and communicate with each other.

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:

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

Frequently asked questions about Bilevon

What is Bilevon?

Bilevon (NICLOFOLAN) is a niclofolan drug.

How does Bilevon work?

Bilevon works by inhibiting the ATPase activity of the calcium pump in the plasma membrane of certain cells.

What is the generic name of Bilevon?

NICLOFOLAN is the generic (nonproprietary) name of Bilevon.

What drug class is Bilevon in?

Bilevon belongs to the niclofolan class. See all niclofolan drugs at /class/niclofolan.

What development phase is Bilevon in?

Bilevon is in Phase 2.

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

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