In 2025, endocrinology moved decisively toward outcomes that change long-term risk, earlier interception of disease, and access mechanics—biosimilars, devices, and workflow-ready screening—that determine real-world adoption.
Three Shifts That Defined Endocrinology in 2025
Outcomes Replaced Proxies as the New Standard in Endocrinology
A1c still mattered, but 2025 reinforced that what gets defended on formularies—and what executives can credibly scale—now hinges on event-level and organ-level benefit: MACE data for oral semaglutide, kidney-risk reduction for injectable semaglutide in Canada, and an expanding cardiovascular narrative around tirzepatide in high-risk type 2 diabetes.
In 2025 earlier intervention in Endocrinology became operational, not aspirational.
Prevention-stage type 1 diabetes accelerated from concept to systems work: the UK MHRA approved teplizumab to delay stage 3 onset by approximately three years, CHMP moved it forward in Europe, and structured NHS pathway work emphasized autoantibody confirmation, monitoring cadence, and practical decision points for children with early-stage disease.
Access and Scalability Emerged as the Key Differentiators in Endocrinology in 2025
Denosumab biosimilars accumulated across the EU, Canada, the US, and select Asian markets—then crossed into interchangeability in the United States, unlocking substitution dynamics. In parallel, diabetes technology (including longer-wear CGM and pump/CGM integration) and digital support models matured into adoption levers that increasingly sit alongside the drug itself.
Practice-shaping Endocrinology readouts that defined 2025
1) SOUL put oral semaglutide into risk-reduction territory
The SOUL phase 3b cardiovascular outcomes dataset for oral semaglutide delivered a fourteen percent relative risk reduction in MACE versus placebo, with a reported twenty-seven percent reduction in Asian participants and benefit observed with and without concomitant SGLT2 inhibitor use.
That evidence translated into an FDA cardiovascular risk-reduction indication for Rybelsus, giving oral therapy a clearer outcomes-based value proposition—clinically meaningful, and commercially relevant in markets where payer conversations increasingly demand hard endpoints.
2) FLOW moved semaglutide’s value proposition deeper into cardio-renal protection
Canada made kidney outcomes “real” in practice: Health Canada approved Ozempic for reducing progression of kidney disease in type 2 diabetes, citing FLOW findings of a twenty-four percent reduction in risk of kidney deterioration or failure, plus additional cardiovascular mortality benefit.
The strategic implication is straightforward: when kidney protection becomes part of labeling, it changes sequencing logic, contracting narratives, and the bar for competitors trying to claim comparable value with surrogate-only packages.
3) Tirzepatide expanded from best-in-class efficacy into durable positioning—and real-world friction
In high-risk type 2 diabetes, tirzepatide showed superiority versus dulaglutide in SURPASS-CVOT, supporting an increasingly integrated diabetes–cardiovascular positioning story.
Switching dynamics also sharpened: SURPASS-Switch reported HbA1c down one point forty-four percent and weight down by over ten kilograms, with no major safety concerns identified in that summary.
At the same time, real-world analysis underscored execution risk: dose escalation was slower than in trials, with fifty-five percent adherence and fifty-four percent persistence, a reminder that support infrastructure can be as value-defining as headline efficacy.
4) Pediatric type 2 diabetes moved closer to evidence-driven incretin use
In SURPASS-Peds (n=99, background metformin or insulin), tirzepatide achieved a mean HbA1c reduction of two point two percent versus zero point zero five percent with placebo at thirty weeks, with dose-dependent BMI reductions and safety aligned with the incretin class; effects were sustained through fifty-two weeks, and a filing for label expansion was underway.
5) Supportive care produced outcomes-grade signals in diabetes comorbidity management
A large Swedish registry analysis associated CPAP prescription with a twenty-six percent reduction in all-cause mortality among adults with type 2 diabetes and obstructive sleep apnea after adjustment, while acknowledging limitations typical of observational datasets (including missing OSA severity and adherence data).
Even with caveats, the business and clinical signal is consistent with 2025’s broader theme: integrated pathways—sleep evaluation, adherence support, and follow-up—can deliver outcome-relevant impact and deserve to be treated as strategic assets rather than add-ons.
Endocrinology Approvals, guidelines, and access decisions in 2025
United States: outcomes labeling, oral endocrine innovation, and substitution dynamics
The FDA added a cardiovascular risk-reduction indication to Rybelsus (oral semaglutide) on the back of the SOUL trial.
The agency also approved Palsonify (paltusotine) for acromegaly in adults not controlled by—or unsuitable for—surgery, positioning it as the first once-daily oral SST2 agonist.
On bone health and substitution dynamics, the FDA approved denosumab biosimilars and later granted interchangeability to multiple denosumab biosimilar products—enabling pharmacy substitution per state law.
Europe and the United Kingdom: type 1 interception pathways and guideline structure
In type 1 diabetes interception, the UK MHRA approved teplizumab to delay progression to stage 3 by approximately three years in at-risk individuals.
CHMP issued a positive opinion for teplizumab to delay progression to stage 3 in Europe, with a European Commission decision next.
Implementation also moved: Diabetes UK highlighted an NHS pathway for children with early-stage type 1 diabetes, including autoantibody confirmation, monitoring cadence, and how to handle single-autoantibody presentations.
The European Society of Endocrinology revised its adult hypoparathyroidism guideline, redefining chronic postsurgical disease at twelve months and outlining an algorithm for when to consider PTH therapy after conventional management.
Canada: kidney outcomes on-label and biosimilar competition
Health Canada approved Ozempic for reducing kidney disease progression in type 2 diabetes (FLOW).
Health Canada also approved Celltrion’s denosumab biosimilars (Stoboclo for osteoporosis; Osenvelt for oncology-related bone complications and giant cell tumor of bone).
China and broader Asia: new entrants and explicit access catalysts
China’s NMPA approved mazdutide, described as the first dual glucagon and GLP-1 receptor agonist for glycemic control in adults with type 2 diabetes, based on phase 3 trials in Chinese participants showing superior reductions in HbA1c and weight versus placebo and dulaglutide, with safety consistent with the incretin class.
Mounjaro was reported to be added to China’s national health insurance scheme starting January 1, 2026, an explicit near-term access catalyst.
Thailand approved a denosumab biosimilar, framed as a step toward expanding access for osteoporosis and cancer-related bone loss.
Emerging-market execution and partnerships: launches and local commercialization mechanics
In India, Biocon received approval for liraglutide for type 2 diabetes in patients aged ten years and above.
Lilly launched Mounjaro KwikPen with multiple dosage strengths.
ement with Laboratorios Silanes for combination diabetes drugs.
Safety and Supportive Care in Endocrinology 2025: Keeping Patients on Therapy
In 2025, persistence was shaped by safety guardrails, rescue tools, and workflow simplification—especially as biosimilars and devices scaled.
Biosimilar substitution required consistent risk management.
Denosumab biosimilar labels highlighted risks of severe hypocalcemia (especially in chronic kidney disease) and osteonecrosis of the jaw, with dental precautions emphasized; as interchangeability expanded, consistent risk management became central to payer and prescriber confidence.
Rescue and prevention tools expanded the safety toolkit.
Lupin launched a glucagon emergency injection kit in the United States (bioequivalent to Eli Lilly’s version) for severe hypoglycemia in adults and children.
For prevention of nocturnal hypoglycemia, Zucara began phase 2 testing of ZT-01 in type 1 diabetes in the United States and Canada.
Digital monitoring reduced friction—but quality events mattered.
IBM and Roche launched Accu-Chek SmartGuide Predict, an AI-powered app using CGM data to forecast trends two hours ahead and alert potential hypoglycemia thirty minutes in advance.
Abbott recalled certain FreeStyle Libre 3 and Libre 3 Plus sensors due to incorrect low-glucose readings, with reports of adverse events including deaths tied to insulin mismanagement following inaccurate readings.
Psychosocial burden moved into formal practice.
EASD issued its first clinical practice guideline on diabetes distress, recommending routine assessment and evidence-based psychological or psychoeducational support.
Diagnostics, Stratification, and Measurement in Endocrinology 2025: Better Matching, Better Endpoints
The diagnostic storyline of 2025 was about building scalable funnels—screening, risk stratification, and monitoring that can justify earlier intervention.
For type 1 diabetes, Revvity and Sanofi advanced plans for a four-plex autoantibody IVD on the Revvity GSP platform, with clinical validation and regulatory submissions planned across the US, Europe, and other regions.
Sanofi also launched an early detection study in Gulf countries screening children and adolescents with a first-degree relative for islet autoantibodies, with metabolic testing for positives.
In risk prediction, AI tools aimed to compress complexity into deployable screening. One set of models predicted insulin resistance using fasting glucose plus basic physical metrics (waist circumference and BMI), with the Mets-IR model achieving an AUC greater than zero point nine seven and external validation in that summary.
In pregnancy, an Austrian-led multicentre cohort (n=657 across Austria, Germany, Switzerland) found early OGTT glucose values (fasting, sixty, one hundred twenty minutes) predicted later gestational diabetes and the need for insulin.
A Singapore team described a first-trimester biomarker blood test that could predict gestational diabetes without fasting and potentially replace the multi-hour OGTT.
Endocrine oncology and bone health also advanced through measurement-driven tools. A radiomics-based AI nomogram reported ninety-four percent diagnostic accuracy for predicting lymph node recurrence in thyroid cancer.
A study of more than 4,400 patients identified postoperative thyroglobulin antibody levels above four hundred forty international units per milliliter as a strong predictor of papillary thyroid cancer recurrence (six-fold higher odds of relapse in that summary).
AI applied to routine chest X-rays was described as cost-effective for osteoporosis detection (under one hundred thousand dollars per QALY), contingent on follow-up and adherence.
Endocrinology Catalyst Calendar: Timelines Explicitly Flagged in 2025
Late 2025
- October 2025 (expected): Modular Medical planned a special FDA 510(k) submission for its Pivot Patch Insulin Pump.
January 2026
- January 1, 2026: Mounjaro was reported to be added to China’s national health insurance scheme.
2026
- 2026 (results expected): Sanofi SAR442970 phase 2a program in newly diagnosed type 1 diabetes was described with results expected in 2026.
May 2026
- May 29, 2026: FDA target action date for MannKind’s Afrezza pediatric sBLA (ages 4–17), supported by phase 3 INHALE-1.
Mid–Q3 2026
- Mid–Q3 2026 (company runway guidance): Entera Bio reported cash to fund operations through mid–third quarter 2026 as it moved into phase 3 for EB613 (oral anabolic osteoporosis candidate; BMD primary endpoint).
Key Endocrinology Takeaways for 2025
Endocrinology in 2025 wasn’t defined by a single molecule—it was defined by a systems shift: outcomes-forward labeling (CV and kidney), earlier interception (especially in type 1 diabetes), and scalable delivery (biosimilar leverage, device integration, and standardized screening pathways). The next winners will pair strong data with deployable delivery.
🚀 Accelerate your success. Contact us now
📂 Explore our case studies. See examples of our work.
💡 Read our insights. Learn from our latest reports and analysis
🎬 Watch on YouTube. Subscribe and never miss a video.
🧰 See our full range of services. Discover how we can help you.
📚 View the full Endocrinology archive on our research hub page.