Last reviewed 2026-05-22 · How we verify

Anassicol (DIMETOFRINE)

Phase 2 active Small molecule ✓ Verified May 2026

Anassicol (generic name: DIMETOFRINE) is a dimetofrine drug. It is currently in Phase 2 development.

Anassicol works by interacting with a specific target, but its exact mechanism is currently unknown.

Anassicol is a small molecule with synonyms including Dimethophrine, Dimetofrine, and Dimetofrine.

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	DIMETOFRINE
Drug class	dimetofrine
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and Anassicol is a key that fits into one of those locks. When it binds, it can either unlock or block the normal functioning of the cell, but we don't know which yet. This interaction can potentially affect various cellular processes, but more research is needed to understand how it works.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Treatment of Depression Following Multiple Brain Tests (PHASE4)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

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

Frequently asked questions about Anassicol

What is Anassicol?

Anassicol (DIMETOFRINE) is a dimetofrine drug.

How does Anassicol work?

Anassicol works by interacting with a specific target, but its exact mechanism is currently unknown.

What is the generic name of Anassicol?

DIMETOFRINE is the generic (nonproprietary) name of Anassicol.

What drug class is Anassicol in?

Anassicol belongs to the dimetofrine class. See all dimetofrine drugs at /class/dimetofrine.

What development phase is Anassicol in?

Anassicol is in Phase 2.

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

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