Last reviewed 2026-05-20 · How we verify

Restas (FLUTOPRAZEPAM)

Phase 2 active Small molecule ✓ Verified May 2026

Restas (generic name: FLUTOPRAZEPAM) is a flutoprazepam drug. It is currently in Phase 2 development for Induction of general anesthesia, Insomnia.

Flutoprazepam works by enhancing the activity of the neurotransmitter gamma-aminobutyric acid (GABA) in the brain.

Restas is a small molecule. It is also known by the synonyms Flutoprazepam and Restas.

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	FLUTOPRAZEPAM
Drug class	flutoprazepam
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your brain is like a busy city with many people talking and moving around. GABA is like a quieting signal that helps slow down the activity in the city. Flutoprazepam increases the strength of this signal, making it easier for the brain to relax and fall asleep, or to induce general anesthesia.

Approved indications

Induction of general anesthesia
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:

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

Frequently asked questions about Restas

What is Restas?

Restas (FLUTOPRAZEPAM) is a flutoprazepam drug, indicated for Induction of general anesthesia, Insomnia.

How does Restas work?

Flutoprazepam works by enhancing the activity of the neurotransmitter gamma-aminobutyric acid (GABA) in the brain.

What is Restas used for?

Restas is indicated for Induction of general anesthesia, Insomnia.

What is the generic name of Restas?

FLUTOPRAZEPAM is the generic (nonproprietary) name of Restas.

What drug class is Restas in?

Restas belongs to the flutoprazepam class. See all flutoprazepam drugs at /class/flutoprazepam.

What development phase is Restas in?

Restas is in Phase 2.

Drug class: All flutoprazepam drugs
Therapeutic area: All drugs in Neuroscience
Indication: Drugs for Induction of general anesthesia
Indication: Drugs for Insomnia

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