Akums launches DCGI-approved Dapagliflozin combo 2025

Launch signals push toward fixed-dose diabetes combinations

Akums Drugs and Pharmaceuticals has launched a combination tablet of dapagliflozin and pioglitazone for the management of type 2 diabetes. The company positions the product as an option for patients who struggle to maintain stable blood sugar control on conventional regimens, including metformin-based treatments. The launch adds to a wider stream of fixed-dose combinations (FDCs) that Akums has been introducing across therapy areas. The key regulatory anchor for the product is approval from the Drug Controller General of India (DCGI). Akums also said the formulation underwent a rigorous bioequivalence study. In practical terms, the move highlights how manufacturers are packaging complementary mechanisms into a single daily pill to address adherence and multi-pathway control.

What has been launched and who it is for

The product is marketed as Dapagliflozin + Pioglitazone tablets, intended for type 2 diabetes management. Akums describes it as a dual-action formulation aimed at both glycaemic control and insulin resistance. The company’s communication links the launch to a common clinical situation: patients who do not achieve consistent control with older or single-drug approaches. It also notes that conventional treatments can fall short in maintaining stable blood sugar levels. In that context, Akums frames the combination as a way to reduce glucose fluctuations more effectively than monotherapy. The company also points to a broader objective of addressing hurdles seen in diabetes care, including treatment failure and the need for frequent medication adjustments.

DCGI approval and bioequivalence study

Akums said the formulation has been approved by the Drug Controller General of India (DCGI). It also stated that the product has undergone a rigorous bioequivalence study, and that the approval validates safety and therapeutic efficacy. For combination therapies, regulatory clearance and bioequivalence data are central to physician confidence, particularly when a product is positioned as an alternative to existing regimens. The announcement does not provide study design details or numerical endpoints, but it explicitly links the approval to the completed bioequivalence work. The company’s emphasis on DCGI approval is consistent with its recent pattern of launching DCGI-approved FDCs in other categories as well.

How dapagliflozin contributes to glucose control

Dapagliflozin is described as a sodium-glucose co-transporter 2 (SGLT2) inhibitor. Akums notes that it helps eliminate excess glucose through urine, supporting glucose lowering through a mechanism distinct from insulin secretion. The company also highlights additional benefits associated with the molecule, including improved cardiovascular and renal outcomes and better weight management. In a separate regulatory context referenced in the material, dapagliflozin is also described as being indicated to reduce the risk of cardiovascular death, hospitalisation for heart failure, and urgent heart failure visits in adults with heart failure, and to reduce the risk of hospitalisation for heart failure in adults with type 2 diabetes and cardiovascular risk.

How pioglitazone targets insulin resistance

Pioglitazone is positioned as an insulin sensitiser. Akums states that it augments insulin sensitivity in key tissues such as muscle and liver, which addresses insulin resistance. This mechanism is presented as complementary to dapagliflozin’s glucose excretion pathway. By targeting insulin resistance, pioglitazone is framed as working on a root metabolic issue rather than only lowering circulating glucose. Akums also links the combination to sustained results and fewer hurdles that can complicate diabetes therapy.

Why the combination is positioned over monotherapy

Akums argues that single-drug regimens may offer only partial benefits, while the combined action provides superior control and reduces fluctuations in glucose levels more effectively. The company states that the dual-drug approach addresses multiple metabolic pathways simultaneously, leading to more effective glucose regulation. It also says the combination reduces the likelihood of treatment failure and the need for frequent medication adjustments. The product is also positioned for patients who struggle with existing metformin-based regimens, suggesting it may be considered when current therapy does not deliver stable control. While these claims are presented qualitatively, the thrust of the message is that complementary mechanisms can cover more than one driver of hyperglycaemia.

Safety and tolerability points highlighted by Akums

Akums states that the combination aims to minimise risks such as hypoglycaemia and weight gain, described as common hurdles in diabetes care. It links these risk reductions to the overall pairing of mechanisms, and to the objective of sustained blood sugar control. The company also reiterates DCGI approval and the completed bioequivalence study as the basis for confidence in the formulation’s safety and therapeutic efficacy. No additional safety data, warnings, or label specifics are included in the provided material. As with all anti-diabetic combinations, prescribing decisions typically account for patient profile and comorbidities, but the announcement itself stays focused on the stated advantages.

Once-daily dosing and adherence focus

The company notes that once-daily dosing is expected to improve patient adherence. That matters in type 2 diabetes, where multi-drug regimens often increase pill burden over time. Akums also ties the combination approach to reducing the need for frequent medication adjustments, which can be a practical issue in long-term disease management. The adherence point is presented as an expected benefit rather than a quantified outcome, but it aligns with the broader rationale for fixed-dose combinations.

Akums’ broader portfolio of DCGI-approved combinations

The launch sits alongside other Akums combination products referenced in the provided material. Akums has introduced Amlodipine, Telmisartan & Metoprolol (ER) film-coated tablets, described as a DCGI-approved fixed-dose combination for the management of uncontrolled essential hypertension with stable coronary artery disease, and also referenced as being for resistant hypertension with stable coronary artery disease. The company has also launched Rabeprazole and Levosulpiride SR capsules for gastrointestinal tract disorders following DCGI approval. Separately, Akums said it received DCGI approval for a triple combination diabetes medication combining Sitagliptin 100, Pioglitazone 15 and Metformin 1000/500, and indicated the intent to reduce the need for patients to swallow multiple drugs. In that statement, Joint Managing Director Sandeep Jain highlighted the combined rationale of metformin, pioglitazone and sitagliptin as an effective solution for diabetes.

Regulatory backdrop: SEC permission for a separate dapagliflozin FDC trial

Beyond launches, the material also references an update from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO). The SEC granted permission to Akums to conduct a phase III clinical trial for a different fixed drug combination: Dapagliflozin plus Bisoprolol Fumarate film-coated tablets. This followed Akums presenting a phase III protocol for two strengths, Bisoprolol 5mg/10mg + Dapagliflozin 10mg/10mg tablets, along with a request for a bioequivalence study waiver. The SEC review for cardiovascular was held on 5 June 2024. This item is distinct from the dapagliflozin plus pioglitazone launch but signals continued development activity around dapagliflozin-based combinations.

Key facts at a glance

Timeline of referenced Akums diabetes developments

Why this matters for India’s diabetes treatment landscape

From an industry perspective, the announcement underscores the continued shift toward combination therapies that target more than one metabolic pathway. Akums, positioned as a contract development and manufacturing organisation, is using DCGI approvals to add differentiated products to its portfolio. The company’s message also reflects a common theme in diabetes care: many patients require therapy intensification over time, and fixed-dose combinations can reduce pill burden. At the same time, the provided material does not include pricing, market share targets, or prescription uptake data, so the impact is best viewed as product-line expansion anchored in regulatory clearance.

Conclusion

Akums’ launch of DCGI-approved dapagliflozin plus pioglitazone tablets adds a dual-mechanism option for type 2 diabetes, backed by a bioequivalence study and positioned for once-daily use. The company is also active in developing and launching other DCGI-cleared fixed-dose combinations, and has received SEC permission to run a phase III trial for a separate dapagliflozin-based cardiovascular combination. Next milestones to watch, based on the provided information, are further regulatory updates on Akums’ ongoing clinical trial programme and additional DCGI approvals for its pipeline of combination products.