Last reviewed 2026-05-25 · How we verify

Timostenil (CAROXAZONE)

Phase 2 active Small molecule ✓ Verified May 2026

Timostenil (generic name: CAROXAZONE) is a caroxazone drug. It is currently in Phase 2 development for Depressive disorder.

Timostenil is thought to work by modulating neurotransmitter activity in the brain.

Timostenil is a small molecule modality. It is also known by the synonyms CAROXAZONA, CAROXAZONE, CAROXAZONE, F.I. 6654, and FI-6654.

Likelihood of approval

12.3% 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).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

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	CAROXAZONE
Drug class	caroxazone
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

In simple terms, Timostenil is believed to help regulate the balance of chemicals in the brain that affect mood, such as serotonin and dopamine. This can help alleviate symptoms of depression, but the exact way it does this is not yet fully understood.

Approved indications

Depressive disorder

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:

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

Frequently asked questions about Timostenil

What is Timostenil?

Timostenil (CAROXAZONE) is a caroxazone drug, indicated for Depressive disorder.

How does Timostenil work?

Timostenil is thought to work by modulating neurotransmitter activity in the brain.

What is Timostenil used for?

Timostenil is indicated for Depressive disorder.

What is the generic name of Timostenil?

CAROXAZONE is the generic (nonproprietary) name of Timostenil.

What drug class is Timostenil in?

Timostenil belongs to the caroxazone class. See all caroxazone drugs at /class/caroxazone.

What development phase is Timostenil in?

Timostenil is in Phase 2.

Drug class: All caroxazone drugs
Therapeutic area: All drugs in Neuroscience
Indication: Drugs for Depressive disorder

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