Last reviewed 2026-05-28 · How we verify

Veronal (BARBITAL)

Phase 2 active Small molecule Under review

Veronal (generic name: BARBITAL) is a barbital drug. It is currently in Phase 2 development for Insomnia.

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

Veronal is a small molecule with the synonym Barbital Sodium, and it has been studied in various clinical trials for conditions such as chronic disease, diabetes, vascular diseases, chronic lung disease, and cancer. These trials have compared telemedicine interventions, including the use of tablets and possibly tools for measurements, to standard care.

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	BARBITAL
Drug class	barbital
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 calming police officer that helps to quiet down the city and make it easier to sleep. Veronal 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.

Key clinical trials

Pragmatic Randomized Control Trial of Telehealth vs Standard Care in Follow-up of Patients With Chronic Conditions (NA)

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:

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

Frequently asked questions about Veronal

What is Veronal?

Veronal (BARBITAL) is a barbital drug, indicated for Insomnia.

How does Veronal work?

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

What is Veronal used for?

Veronal is indicated for Insomnia.

What is the generic name of Veronal?

BARBITAL is the generic (nonproprietary) name of Veronal.

What drug class is Veronal in?

Veronal belongs to the barbital class. See all barbital drugs at /class/barbital.

What development phase is Veronal in?

Veronal is in Phase 2.

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

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