Last reviewed 2026-04-20 · How we verify

Cervilane (LOMIFYLLINE)

Phase 2 active Small molecule

Cervilane (generic name: LOMIFYLLINE) is a lomifylline drug. It is currently in Phase 2 development.

Cervilane is believed to work by influencing the body's hormonal balance.

Cervilane, also known as lomifene, is a small molecule drug in the lomifylline class. Its exact target and mechanism of action are unknown, but it is believed to work by influencing the body's hormonal balance. Cervilane is not FDA-approved for any indications, and its commercial status, including patent and generic availability, is unclear. Further research is needed to determine its safety and efficacy. As a result, it is not currently used in clinical practice.

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	LOMIFYLLINE
Drug class	lomifylline
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Think of it like a thermostat in your home. The thermostat helps keep the temperature just right by turning the heating or cooling system on and off. Cervilane is thought to work in a similar way, helping to balance the levels of different hormones in the body.

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:

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

Frequently asked questions about Cervilane

What is Cervilane?

Cervilane (LOMIFYLLINE) is a lomifylline drug.

How does Cervilane work?

Cervilane is believed to work by influencing the body's hormonal balance.

What is the generic name of Cervilane?

LOMIFYLLINE is the generic (nonproprietary) name of Cervilane.

What drug class is Cervilane in?

Cervilane belongs to the lomifylline class. See all lomifylline drugs at /class/lomifylline.

What development phase is Cervilane in?

Cervilane is in Phase 2.

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

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