Last reviewed 2026-04-20 · How we verify

Baylinal (BUTHALITAL)

Phase 2 active Small molecule

Baylinal (generic name: BUTHALITAL) is a buthalital drug. It is currently in Phase 2 development.

Baylinal works by interacting with the central nervous system to produce a sedative effect.

Baylinal (BUTHALITAL) is a small molecule buthalital drug with unknown target and commercial status. Its mechanism of action is not well-documented, and it is not FDA-approved for any indications. As a result, there is limited information available on its pharmacokinetics, safety, and efficacy. Further research is needed to fully understand the properties and potential uses of Baylinal. Its current status as a developmental compound makes it difficult to assess its clinical utility.

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	BUTHALITAL
Drug class	buthalital
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your brain is like a busy city with many different neighborhoods. Baylinal helps calm down the activity in certain neighborhoods, making you feel more relaxed and sleepy. This is achieved by influencing the way neurons communicate with each other, ultimately leading to a decrease in alertness and consciousness.

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:

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

Frequently asked questions about Baylinal

What is Baylinal?

Baylinal (BUTHALITAL) is a buthalital drug.

How does Baylinal work?

Baylinal works by interacting with the central nervous system to produce a sedative effect.

What is the generic name of Baylinal?

BUTHALITAL is the generic (nonproprietary) name of Baylinal.

What drug class is Baylinal in?

Baylinal belongs to the buthalital class. See all buthalital drugs at /class/buthalital.

What development phase is Baylinal in?

Baylinal is in Phase 2.

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

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