Last reviewed 2026-06-02 · How we verify

Nimetazam (NIMETAZEPAM)

Phase 2 active Small molecule ✓ Verified Jun 2026

Nimetazam (generic name: NIMETAZEPAM) is a nimetazepam drug. It is currently in Phase 2 development for Insomnia.

Nimetazepam works by enhancing the activity of the neurotransmitter GABA, which helps to calm the brain and induce sleep.

Nimetazam is a small molecule. It is also known by other names, including ERIMIN, NIMETAZEPAM, S 1530, and S-1530.

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	NIMETAZEPAM
Drug class	nimetazepam
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your brain is like a busy city with lots of noise and activity. GABA is like a traffic cop that helps to slow down the traffic and calm things down. Nimetazepam helps GABA do its job more effectively, making it easier to fall asleep and stay asleep.

Approved indications

Insomnia

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:

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

Frequently asked questions about Nimetazam

What is Nimetazam?

Nimetazam (NIMETAZEPAM) is a nimetazepam drug, indicated for Insomnia.

How does Nimetazam work?

Nimetazepam works by enhancing the activity of the neurotransmitter GABA, which helps to calm the brain and induce sleep.

What is Nimetazam used for?

Nimetazam is indicated for Insomnia.

What is the generic name of Nimetazam?

NIMETAZEPAM is the generic (nonproprietary) name of Nimetazam.

What drug class is Nimetazam in?

Nimetazam belongs to the nimetazepam class. See all nimetazepam drugs at /class/nimetazepam.

What development phase is Nimetazam in?

Nimetazam is in Phase 2.

Drug class: All nimetazepam drugs
Therapeutic area: All drugs in Neuroscience
Indication: Drugs for Insomnia

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