Last reviewed 2026-05-29 · How we verify

Somelin (HALOXAZOLAM)

Phase 2 active Small molecule ✓ Verified May 2026

Somelin (generic name: HALOXAZOLAM) is a haloxazolam drug. It is currently in Phase 2 development.

Somelin works by enhancing the activity of a neurotransmitter called GABA, which helps to calm the brain and reduce anxiety.

Somelin is a small molecule. It is also known by the synonyms HALOXAZOLAM and SOMELIN.

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	HALOXAZOLAM
Drug class	haloxazolam
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your brain is like a busy city with lots of people talking and moving around. GABA is like a traffic cop that helps to slow down the traffic and keep everything calm. Somelin helps the traffic cop do its job more effectively, which can help to reduce feelings of anxiety and promote relaxation.

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:

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

Frequently asked questions about Somelin

What is Somelin?

Somelin (HALOXAZOLAM) is a haloxazolam drug.

How does Somelin work?

Somelin works by enhancing the activity of a neurotransmitter called GABA, which helps to calm the brain and reduce anxiety.

What is the generic name of Somelin?

HALOXAZOLAM is the generic (nonproprietary) name of Somelin.

What drug class is Somelin in?

Somelin belongs to the haloxazolam class. See all haloxazolam drugs at /class/haloxazolam.

What development phase is Somelin in?

Somelin is in Phase 2.

Drug class: All haloxazolam drugs
Therapeutic area: All drugs in Neuroscience

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