Last reviewed 2026-04-20 · How we verify

Bromadal (CARBROMAL)

Phase 2 active Small molecule

Bromadal (generic name: CARBROMAL) is a carbromal drug. It is currently in Phase 2 development for Insomnia.

Bromadal works by enhancing the activity of neurotransmitters in the brain that promote relaxation and sleep.

Bromadal, also known as CARBROMAL, is a small molecule drug in the carbromal class. It is used to treat insomnia, a common sleep disorder. The commercial status of Bromadal is currently unknown, and it may be patented or available as a generic medication. Key safety considerations for Bromadal are not well-documented, but it is essential to follow the recommended dosage and consult a healthcare professional for guidance. Further research is needed to fully understand the pharmacological properties of Bromadal.

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	CARBROMAL
Drug class	carbromal
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your brain has a 'volume control' for different signals. Bromadal helps turn down the volume on signals that keep you awake and alert, making it easier to fall asleep. This is achieved by influencing the activity of neurotransmitters like GABA, which is a key player in regulating sleep and relaxation.

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:

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

Frequently asked questions about Bromadal

What is Bromadal?

Bromadal (CARBROMAL) is a carbromal drug, indicated for Insomnia.

How does Bromadal work?

Bromadal works by enhancing the activity of neurotransmitters in the brain that promote relaxation and sleep.

What is Bromadal used for?

Bromadal is indicated for Insomnia.

What is the generic name of Bromadal?

CARBROMAL is the generic (nonproprietary) name of Bromadal.

What drug class is Bromadal in?

Bromadal belongs to the carbromal class. See all carbromal drugs at /class/carbromal.

What development phase is Bromadal in?

Bromadal is in Phase 2.

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

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