Last reviewed 2026-04-20 · How we verify

Ucedorm (BRALLOBARBITAL)

Phase 2 active Small molecule

Ucedorm (generic name: BRALLOBARBITAL) is a brallobarbital drug. It is currently in Phase 2 development.

Ucedorm works by affecting the activity of neurotransmitters in the brain, which can influence various physiological processes.

Ucedorm, also known as brallobarbital, is a small molecule drug of the barbiturate class. Its exact target and mechanism of action are unknown, but it is believed to work by modulating the activity of neurotransmitters in the brain. Ucedorm is not FDA-approved for any indications, and its commercial status, including whether it is patented or generic, is also unknown. As a result, there is limited information available on its safety profile, half-life, and bioavailability. Further research is needed to fully understand the properties and potential uses of Ucedorm.

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	BRALLOBARBITAL
Drug class	brallobarbital
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Think of neurotransmitters like messengers that help different parts of the brain talk to each other. Ucedorm is thought to either enhance or reduce the activity of these messengers, which can have a range of effects on the body. This can lead to changes in things like mood, sleep, and pain perception.

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:

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

Frequently asked questions about Ucedorm

What is Ucedorm?

Ucedorm (BRALLOBARBITAL) is a brallobarbital drug.

How does Ucedorm work?

Ucedorm works by affecting the activity of neurotransmitters in the brain, which can influence various physiological processes.

What is the generic name of Ucedorm?

BRALLOBARBITAL is the generic (nonproprietary) name of Ucedorm.

What drug class is Ucedorm in?

Ucedorm belongs to the brallobarbital class. See all brallobarbital drugs at /class/brallobarbital.

What development phase is Ucedorm in?

Ucedorm is in Phase 2.

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

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