Last reviewed 2026-05-23 · How we verify

CICLONIUM

Phase 2 active Small molecule ✓ Verified May 2026

CICLONIUM is a ciclonium drug. It is currently in Phase 2 development.

Ciclonium works by interacting with a specific target in the body to produce a therapeutic effect.

Ciclonium is a small molecule medication with the chemical name Ciclonium bromide, also known as ASTA 3746 or Ciclonium bromide.

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	CICLONIUM
Drug class	ciclonium
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Unfortunately, the exact mechanism of action of ciclonium is not well understood, and more research is needed to determine how it produces its effects in the body. In general, small molecule drugs like ciclonium are designed to bind to specific proteins or receptors in the body, which can help to regulate various physiological processes. By altering the activity of these proteins or receptors, ciclonium may help to treat certain medical 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:

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

Frequently asked questions about CICLONIUM

What is CICLONIUM?

CICLONIUM is a ciclonium drug.

How does CICLONIUM work?

Ciclonium works by interacting with a specific target in the body to produce a therapeutic effect.

What drug class is CICLONIUM in?

CICLONIUM belongs to the ciclonium class. See all ciclonium drugs at /class/ciclonium.

What development phase is CICLONIUM in?

CICLONIUM is in Phase 2.

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

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