Cirius Therapeutics Announces Gestational Diabetes Initiative

• Supported by a Gates Foundation grant
• Addressing postpartum health burdens of gestational diabetes
• Gestational diabetes occurs in up to 20% of pregnancies
• Marked increases in subsequent chronic metabolic diseases for women who experience gestational diabetes

GRAND RAPIDS, Mich., April 28, 2026 /PRNewswire/ -- Cirius Therapeutics, Inc., a developer of innovative therapies for people suffering from diseases caused by mitochondrial dysfunction and insulin resistance, today announced a planning grant from the Gates Foundation to advance the development of CIR‑0602K as a potential postpartum therapeutic for women with a history of gestational diabetes mellitus (GDM).

This planning grant can potentially inform a multi‑stage development program to generate scientific and clinical evidence supporting CIR-0602K for postpartum use in women who develop GDM during pregnancy. The initial grant supports a planning and preparation phase for examining potential exposure of CIR-0602K in breast milk, with the objective of enabling future clinical studies in women immediately postpartum, subject to outcomes and regulatory feedback.

GDM affects an estimated 10–20% of pregnancies worldwide, both in the U.S./Europe and in low‑ and middle‑income countries (LMIC). It substantially increases a woman's risk of developing type 2 diabetes and other cardiometabolic complications following delivery, often within the first year. These risks are particularly problematic in LMIC, where postpartum screening and therapeutic interventions are often limited or unavailable.

"With funding support from the Gates Foundation, this work reflects a shared interest in improving cardiometabolic health, including for new mothers who we know are at high risk of serious and debilitating chronic disease, but for whom there are few options," said Dr. Robert Beardsley, Ph.D., Chief Executive Officer of Cirius Therapeutics. "While the current grant focuses on planning and regulatory alignment, it is the foundation for potential future clinical efficacy trials. Our goal is to work together over time to execute studies that could ultimately support CIR-0602K as a safe and effective globally relevant treatment option."

The outputs from this planning phase will potentially inform the design, regulatory expectations and execution of subsequent clinical studies, including trials conducted in LMIC settings. As part of this planning phase, Cirius will also work with Certara, a global leader in model-informed drug development, bringing specialized expertise in maternal–fetal and lactation modeling. Using the Simcyp® Simulator, Certara scientists can predict drug exposure in breastfeeding mothers and infants, populations that are historically under-represented in clinical research.

"Advancing safe and effective postpartum therapies requires a deliberate, stepwise approach, particularly when addressing lactation and infant safety," said Karen R. Yeo, Senior Vice President, Client & Regulatory Strategy at Certara. "This phase is structured to first build the evidence base needed to responsibly move toward clinical evaluation, with the longer‑term objective of enabling trials that can inform postpartum care globally."

CIR‑0602K is an orally administered MPC inhibitor that has been evaluated in multiple Phase 2 studies across cardiometabolic indications. If future studies demonstrate safety and efficacy in the postpartum setting, the therapy could offer a practical and scalable intervention to reduce progression to type 2 diabetes, kidney disease and other chronic metabolic diseases following GDM.

The compound's profile may be particularly advantageous for use in resource‑limited settings. Cirius has committed to managing all project outputs in alignment with the Gates Foundation's Global Access principles, ensuring early consideration of affordability, accessibility, and relevance for LMIC populations.

About Cirius
Cirius is a clinical-stage pharmaceutical company focusing on metabolic health via targeting mitochondrial pyruvate carrier (MPC), addressing the mitochondrial dysfunction that causes insulin resistance and the organ pathologies associated with type 2 diabetes (T2D), type 1 diabetes (T1D) and obesity/overweight. Its lead product candidate, CIR-0602K, is a potential best-in-class novel small molecule being developed as a once-daily oral therapy designed to selectively inhibit the mitochondrial target MPC, which plays a central role in selecting mitochondrial energy substrates. MPC inhibition reprograms mitochondrial metabolism, reducing insulin resistance in cells and driving metabolic benefits in organs throughout the body. This markedly improves glycemic control in diabetes, body composition in obesity, liver function and fibrosis in metabolic dysfunction-associated steatohepatitis (MASH), and outcomes in cardiometabolic disorders.

About CIR-0602K
CIR-0602K has completed 7 US clinical trials including a 52-week placebo-controlled Phase 2b study in 392 participants with MASH with and without T2D, and a 28-day placebo-controlled Phase 2a study in 129 participants with T2D. In those clinical studies it lowered HbA1c and insulin levels, and reduced liver injury and MASH – including on top of existing GLP-1 therapy. A pilot clinical study also showed CIR-0602K markedly reduces HbA1c, insulin levels and fat in muscle, and increases muscle metabolic function in people with obesity & T2D. A Phase 2a study in people with type 1 diabetes (T1D) and supported by Breakthrough T1D began enrolling participants in early 2026.

Preclinical studies also demonstrate increased lean muscle mass, strength and metabolic function, together with metabolically beneficial shifts in adipose tissue phenotype ("bad fat" to "good fat"), both alone and on top of GLP-1 and GLP-1/GIP agonists. In combination with GLP-1/GIP dual agonist tirzepatide, the synergistic transformation of subcutaneous adipose tissue includes dramatic reduction in adipocyte size and increase in "beiging." Selectively targeting MPC – while avoiding PPAR-γ activation – CIR-0602K harnesses the real-world proven efficacy of 1^st generation insulin sensitizers, such as pioglitazone, but without their side effect concerns.

Directly correcting a major underlying pathophysiology of chronic metabolic disease, CIR-0602K has the potential to become a cornerstone of therapy. Coupling this potent pharmacology with that of the GLP-1s could particularly benefit patients with T2D, T1D, obesity/overweight, MASH and other cardiometabolic diseases.

www.CiriusTx.com

Contact:
[email protected]

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SOURCE Cirius Therapeutics