Last reviewed 2026-04-20 · How we verify

Buramat (BURAMATE)

Phase 2 active Small molecule

Buramat (generic name: BURAMATE) is a buramate drug. It is currently in Phase 2 development.

Buramate works by interacting with a specific molecular target to produce a therapeutic effect.

Buramate (BURAMATE) is a small molecule drug in the buramate class, but specific details about its development, approval status, and indications are not available. As a pharma professional, further research is necessary to understand its target, mechanism of action, and commercial status. The drug's half-life, bioavailability, and generic manufacturers are also unknown. Buramate's safety considerations and potential side effects cannot be determined without more information. Further investigation is required to determine its current status and potential applications.

Likelihood of approval

15.3% 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).

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	BURAMATE
Drug class	buramate
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and the key to unlocking the right response is a specific molecule. Buramate is designed to fit into these locks, allowing the cell to respond in a way that treats a particular condition. This is a simplified explanation of how buramate works at a molecular level.

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:

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

Frequently asked questions about Buramat

What is Buramat?

Buramat (BURAMATE) is a buramate drug.

How does Buramat work?

Buramate works by interacting with a specific molecular target to produce a therapeutic effect.

What is the generic name of Buramat?

BURAMATE is the generic (nonproprietary) name of Buramat.

What drug class is Buramat in?

Buramat belongs to the buramate class. See all buramate drugs at /class/buramate.

What development phase is Buramat in?

Buramat is in Phase 2.

Drug class: All buramate drugs
Therapeutic area: All drugs in Other

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