Last reviewed 2026-05-23 · How we verify

MSDC-0602K

Cirius Therapeutics, Inc. · Phase 3 active Small molecule ✓ Verified May 2026

MSDC-0602K is a Mitochondrial pyruvate carrier activator / Thiazolidinedione-like insulin sensitizer Small molecule drug developed by Cirius Therapeutics, Inc.. It is currently in Phase 3 development for Type 2 diabetes mellitus, Non-alcoholic fatty liver disease (NAFLD) / Non-alcoholic steatohepatitis (NASH).

MSDC-0602K is a thiazolidinedione-class insulin sensitizer that activates mitochondrial pyruvate carrier (MPC) to improve insulin sensitivity and glucose metabolism.

MSDC-0602K is being studied in clinical trials for conditions including Non-alcoholic Steatohepatitis and Type 2 Diabetes. MSDC-0602K is an insulin sensitizer designed to retain the effect of thiazolidinediones on mitochondrial pyruvate carriers with limited PPAR-gamma binding.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	MSDC-0602K
Sponsor	Cirius Therapeutics, Inc.
Drug class	Mitochondrial pyruvate carrier activator / Thiazolidinedione-like insulin sensitizer
Target	Mitochondrial pyruvate carrier (MPC)
Modality	Small molecule
Therapeutic area	Metabolic / Endocrinology
Phase	Phase 3

Mechanism of action

The drug targets the mitochondrial pyruvate carrier complex, enhancing pyruvate transport into mitochondria and improving cellular energy metabolism. This mechanism increases insulin sensitivity and reduces hepatic glucose production, making it potentially beneficial for metabolic disorders including type 2 diabetes and non-alcoholic fatty liver disease (NAFLD).

Approved indications

Type 2 diabetes mellitus
Non-alcoholic fatty liver disease (NAFLD) / Non-alcoholic steatohepatitis (NASH)

Common side effects

Weight gain
Fluid retention / edema
Hypoglycemia
Gastrointestinal disturbances

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:

MSDC-0602K CI brief — competitive landscape report
MSDC-0602K updates RSS · CI watch RSS
Cirius Therapeutics, Inc. portfolio CI

Frequently asked questions about MSDC-0602K

What is MSDC-0602K?

MSDC-0602K is a Mitochondrial pyruvate carrier activator / Thiazolidinedione-like insulin sensitizer drug developed by Cirius Therapeutics, Inc., indicated for Type 2 diabetes mellitus, Non-alcoholic fatty liver disease (NAFLD) / Non-alcoholic steatohepatitis (NASH).

How does MSDC-0602K work?

MSDC-0602K is a thiazolidinedione-class insulin sensitizer that activates mitochondrial pyruvate carrier (MPC) to improve insulin sensitivity and glucose metabolism.

What is MSDC-0602K used for?

MSDC-0602K is indicated for Type 2 diabetes mellitus, Non-alcoholic fatty liver disease (NAFLD) / Non-alcoholic steatohepatitis (NASH).

Who makes MSDC-0602K?

MSDC-0602K is developed by Cirius Therapeutics, Inc. (see full Cirius Therapeutics, Inc. pipeline at /company/cirius-therapeutics-inc).

What drug class is MSDC-0602K in?

MSDC-0602K belongs to the Mitochondrial pyruvate carrier activator / Thiazolidinedione-like insulin sensitizer class. See all Mitochondrial pyruvate carrier activator / Thiazolidinedione-like insulin sensitizer drugs at /class/mitochondrial-pyruvate-carrier-activator-thiazolidinedione-like-insulin-sensitizer.

What development phase is MSDC-0602K in?

MSDC-0602K is in Phase 3.

What are the side effects of MSDC-0602K?

Common side effects of MSDC-0602K include Weight gain, Fluid retention / edema, Hypoglycemia, Gastrointestinal disturbances.

What does MSDC-0602K target?

MSDC-0602K targets Mitochondrial pyruvate carrier (MPC) and is a Mitochondrial pyruvate carrier activator / Thiazolidinedione-like insulin sensitizer.

Drug class: All Mitochondrial pyruvate carrier activator / Thiazolidinedione-like insulin sensitizer drugs
Target: All drugs targeting Mitochondrial pyruvate carrier (MPC)
Manufacturer: Cirius Therapeutics, Inc. — full pipeline
Therapeutic area: All drugs in Metabolic / Endocrinology
Indication: Drugs for Type 2 diabetes mellitus
Indication: Drugs for Non-alcoholic fatty liver disease (NAFLD) / Non-alcoholic steatohepatitis (NASH)

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