Last reviewed 2026-05-26 · How we verify

Gondafon (GLYMIDINE)

Phase 2 active Small molecule ✓ Verified May 2026

Gondafon (generic name: GLYMIDINE) is a glymidine drug. It is currently in Phase 2 development for Diabetes mellitus type 2.

Gondafon works by stimulating insulin release from the pancreas.

Gondafon is a small molecule with the synonyms GLIDIAZINE, GLYCODIAZINE, GLYMIDINE, GLYMIDINE, GONDAFON, and REDUL. It has been studied in clinical trials for the treatment of Type 2 Diabetes Mellitus, specifically in combination with DPP-4 inhibitors, GLP-1 analogs, and Sulfonylureas.

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	GLYMIDINE
Drug class	glymidine
Modality	Small molecule
Therapeutic area	Metabolic
Phase	Phase 2

Mechanism of action

In simple terms, Gondafon helps the body produce more insulin, a hormone that regulates blood sugar levels. This can help lower blood sugar levels in people with type 2 diabetes. By improving insulin production, Gondafon can help manage the symptoms of 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:

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

Frequently asked questions about Gondafon

What is Gondafon?

Gondafon (GLYMIDINE) is a glymidine drug, indicated for Diabetes mellitus type 2.

How does Gondafon work?

Gondafon works by stimulating insulin release from the pancreas.

What is Gondafon used for?

Gondafon is indicated for Diabetes mellitus type 2.

What is the generic name of Gondafon?

GLYMIDINE is the generic (nonproprietary) name of Gondafon.

What drug class is Gondafon in?

Gondafon belongs to the glymidine class. See all glymidine drugs at /class/glymidine.

What development phase is Gondafon in?

Gondafon is in Phase 2.

Drug class: All glymidine drugs
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