Last reviewed 2026-04-20 · How we verify

Cyoctol (CIOTERONEL)

Phase 2 active Small molecule

Cyoctol (generic name: CIOTERONEL) is a cioteronel drug. It is currently in Phase 2 development.

Cioteronel works by binding to and inhibiting a specific protein target, although the exact target is unknown.

Cioteronel is a small molecule drug in the cioteronel class, developed by an unknown entity and currently owned by an unknown entity. Its target and exact mechanism of action are unknown. Cioteronel has not been approved by the FDA for any indications. The commercial status of cioteronel is unclear, with no information available on generic manufacturers or patent status. Further research is needed to determine the safety and efficacy of cioteronel.

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	CIOTERONEL
Drug class	cioteronel
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Think of it like a key fitting into a lock. Cioteronel is the key that blocks the action of a specific protein, which is involved in a particular process in the body. By blocking this protein, cioteronel can help to treat certain conditions.

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:

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

Frequently asked questions about Cyoctol

What is Cyoctol?

Cyoctol (CIOTERONEL) is a cioteronel drug.

How does Cyoctol work?

Cioteronel works by binding to and inhibiting a specific protein target, although the exact target is unknown.

What is the generic name of Cyoctol?

CIOTERONEL is the generic (nonproprietary) name of Cyoctol.

What drug class is Cyoctol in?

Cyoctol belongs to the cioteronel class. See all cioteronel drugs at /class/cioteronel.

What development phase is Cyoctol in?

Cyoctol is in Phase 2.

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

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