Last reviewed 2026-04-20 · How we verify

Burcol (CARBUTAMIDE)

Phase 2 active Small molecule

Burcol (generic name: CARBUTAMIDE) is a carbutamide drug. It is currently in Phase 2 development for Diabetes mellitus type 2.

Burcol works by binding to the sulfonylurea receptor 1, Kir6.2, to stimulate insulin release from pancreatic beta cells.

Burcol, also known as carbutamide, is a small molecule drug that targets the sulfonylurea receptor 1, Kir6.2. It is used to treat type 2 diabetes mellitus. The commercial status of Burcol is unknown, but it is classified as a carbutamide drug class. Key safety considerations are not well-documented. Further research is needed to understand its pharmacokinetic properties.

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	CARBUTAMIDE
Drug class	carbutamide
Target	Sulfonylurea receptor 1, Kir6.2
Modality	Small molecule
Therapeutic area	Metabolic
Phase	Phase 2

Mechanism of action

Think of it like a key fitting into a lock. Burcol is the key that unlocks the insulin release mechanism in the pancreas, allowing more glucose to be released into the bloodstream. This helps to lower blood sugar levels in people with type 2 diabetes.

Approved indications

Diabetes mellitus type 2

Common side effects

No common side effects on file.

Key clinical trials

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:

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

Frequently asked questions about Burcol

What is Burcol?

Burcol (CARBUTAMIDE) is a carbutamide drug, indicated for Diabetes mellitus type 2.

How does Burcol work?

Burcol works by binding to the sulfonylurea receptor 1, Kir6.2, to stimulate insulin release from pancreatic beta cells.

What is Burcol used for?

Burcol is indicated for Diabetes mellitus type 2.

What is the generic name of Burcol?

CARBUTAMIDE is the generic (nonproprietary) name of Burcol.

What drug class is Burcol in?

Burcol belongs to the carbutamide class. See all carbutamide drugs at /class/carbutamide.

What development phase is Burcol in?

Burcol is in Phase 2.

What does Burcol target?

Burcol targets Sulfonylurea receptor 1, Kir6.2 and is a carbutamide.

Drug class: All carbutamide drugs
Target: All drugs targeting Sulfonylurea receptor 1, Kir6.2
Therapeutic area: All drugs in Metabolic
Indication: Drugs for Diabetes mellitus type 2

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