Last reviewed 2026-06-02 · How we verify

Citiolase (CITIOLONE)

Phase 2 active Small molecule

Citiolase (generic name: CITIOLONE) is a citiolone drug. It is currently in Phase 2 development.

Citiolone is thought to work by interacting with a specific cellular target to produce a therapeutic effect.

Citiolase, also known as citiolone, is a small molecule drug of the citiolone class. Its exact target and mechanism of action are unknown, but it is being developed for potential therapeutic applications. The commercial status of citiolone is unclear, and it has not been approved by the FDA for any indications. Further research is needed to determine its safety and efficacy. As a result, there is limited information available about its pharmacokinetic properties.

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	CITIOLONE
Drug class	citiolone
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine citiolone as a key that fits into a lock on a cell. When it binds to this lock, it triggers a series of events that ultimately lead to the desired therapeutic outcome. This process can help to modulate various cellular pathways and restore balance to 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:

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

Frequently asked questions about Citiolase

What is Citiolase?

Citiolase (CITIOLONE) is a citiolone drug.

How does Citiolase work?

Citiolone is thought to work by interacting with a specific cellular target to produce a therapeutic effect.

What is the generic name of Citiolase?

CITIOLONE is the generic (nonproprietary) name of Citiolase.

What drug class is Citiolase in?

Citiolase belongs to the citiolone class. See all citiolone drugs at /class/citiolone.

What development phase is Citiolase in?

Citiolase is in Phase 2.

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

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