What treatments for diabetes are scientifically proven and FDA-approved as of 2025?
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Executive summary
As of 2025, the scientifically proven and FDA‑approved treatments for diabetes include multiple medication classes (insulins, GLP‑1 receptor agonists, GIP/GLP‑1 dual agonists, SGLT2 inhibitors, metformin and other oral antihyperglycemics), device-based therapies (continuous insulin delivery systems and automated insulin delivery), and ocular and renal treatments for diabetes complications — with recent 2025 approvals expanding options such as a rapid‑acting insulin biosimilar, ranibizumab continuous‑delivery for diabetic retinopathy and expanded indications for semaglutide [1] [2] [3] [4] [5].
1. Insulin: multiple approved formulations and new biosimilars increasing access
Insulin remains a cornerstone for type 1 diabetes and many people with type 2 diabetes, and the FDA approved the first rapid‑acting insulin biosimilar Merilog (insulin‑aspart‑szij) in February 2025 — available as a prefilled pen and vial and intended to lower mealtime blood sugar spikes — joining earlier long‑acting insulin biosimilars and signaling agency efforts to improve insulin affordability and competition [1] [6].
2. Injectable incretin therapies: GLP‑1s and the dual GIP/GLP‑1 class with expanding indications
GLP‑1 receptor agonists like semaglutide have established glycemic and cardiovascular benefits and in 2025 semaglutide (Ozempic) received an FDA label expansion to reduce progression of chronic kidney disease, kidney failure and cardiovascular death in adults with type 2 diabetes and CKD, reflecting robust outcome trial evidence; separately, tirzepatide (Mounjaro), a GIP/GLP‑1 dual agonist, is FDA‑approved to improve glycemic control in adults with type 2 diabetes [3] [4] [7] [8].
3. Oral antihyperglycemics and SGLT2 inhibitors: blood sugar control plus organ protection
A broad set of FDA‑approved oral agents — including metformin and classes such as SGLT2 inhibitors — are standard for type 2 diabetes; SGLT2 inhibitors in particular have emerged as essential for patients with diabetes and cardiovascular or kidney disease because of outcome data incorporated into labels and practice guidance [5] [9] [10].
4. Complication‑targeted therapies: eye and kidney treatments approved in 2025
Regulatory decisions in 2025 widened treatments aimed at diabetes complications: the FDA approved ranibizumab delivered via the Susvimo ocular implant for diabetic retinopathy and diabetic macular edema — a continuous‑delivery option with long dosing intervals for those who previously responded to anti‑VEGF injections — and other approvals address vision loss and renal outcomes tied to diabetic disease [2] [11].
5. Technology: pumps, sensors and automated insulin delivery systems now FDA cleared for wider use
Diabetes technology is an FDA‑approved pillar of care; in 2025 new device approvals and label expansions included automated insulin delivery systems such as Tandem’s Control‑IQ+ and broader use of systems like Omnipod 5 in people with type 2 diabetes, reflecting growing regulatory acceptance of integrated pump‑and‑sensor therapy to improve glycemic outcomes [11] [12].
6. Emerging and investigational therapies: gene, cell and once‑weekly insulins on the horizon (but not yet universally approved)
The regulatory pipeline includes promising approaches — islet cell and gene therapies aiming for functional cures, once‑weekly basal insulins in development, and cell‑based products under expedited review — but while these were active in 2025 reporting, many remain investigational or under review and are not yet established, fully FDA‑approved standard treatments according to the sources provided [13] [5].
7. How to read the approvals: evidence, press releases and commercial context
FDA approvals are grounded in clinical trials and outcomes, yet much of the 2025 reporting also relies on manufacturer press releases and media coverage that emphasize commercial and access narratives; for example, Novo Nordisk and Genentech communications frame semaglutide and Susvimo approvals as major advances while the FDA highlights biosimilar competition — readers should note the overlap of clinical evidence cited in regulatory summaries with corporate messaging when judging real‑world impact [3] [2] [1].
8. Limits of this reporting and practical takeaway
The sources catalog major 2025 approvals and class‑level summaries but do not provide an exhaustive list of every FDA‑approved diabetes drug and device; authoritative registries (FDA drug labels, prescribing information and clinical guidelines) are required to compile the complete, up‑to‑date inventory for individual patient decisions, while the evidence base supports the listed classes and specific 2025 approvals cited here [1] [11] [5] [2] [3].