Last reviewed 2026-04-20 · How we verify

Coreminal (FLUTAZOLAM)

Phase 2 active Small molecule

Coreminal (generic name: FLUTAZOLAM) is a drug. It is currently in Phase 2 development.

Flutazolam is a small molecule that modulates neurotransmitter activity in the brain.

Flutazolam, also known as Coreminal, is a small molecule compound with unknown target and drug class. Its development and current ownership are not publicly disclosed. The compound is not FDA-approved for any indications. The commercial status of flutazolam is unclear, and it is not known whether it is patented or available as a generic. Key safety considerations are unknown due to the lack of available information.

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	FLUTAZOLAM
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your brain is a city with many different neighborhoods, each with its own unique culture and way of communicating. Flutazolam is like a special key that unlocks certain neighborhoods, allowing them to talk to each other in new and different ways. This can help to regulate mood and other brain functions.

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:

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

Frequently asked questions about Coreminal

What is Coreminal?

Coreminal (FLUTAZOLAM) is a Small molecule drug.

How does Coreminal work?

Flutazolam is a small molecule that modulates neurotransmitter activity in the brain.

What is the generic name of Coreminal?

FLUTAZOLAM is the generic (nonproprietary) name of Coreminal.

What development phase is Coreminal in?

Coreminal is in Phase 2.

Therapeutic area: All drugs in Neuroscience

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