Monthly endocrinology bulletin — September 29, 2026

Colleagues: this edition covers what was published, presented or approved between August 30 and September 29, 2026. It was a heavy month for diabetes (three FDA decisions, an ADA/EASD consensus and the opening of the European congress in Milan) and for obesity, but a thin one for thyroid and pituitary-adrenal disease: in those areas we include only what is verifiable and say so rather than pad. Fourteen verified items, four of them from outside North America and Western Europe (China, Argentina, Brazil and the regional congress in Punta Cana).

Diabetes

1. FDA approves once-weekly insulin efsitora alfa (Onswik) for type 2 diabetes

[Regulatory FDA] [United States]
On September 24 the FDA approved efsitora alfa (Lilly), the second once-weekly basal insulin in the United States after icodec, for adults with type 2 diabetes only. The QWINT program (four open-label phase 3 trials, more than 3,400 adults) compared efsitora with glargine U-100 or degludec U-100 using a 0.4-point HbA1c non-inferiority margin: QWINT-1 (n=795, insulin-naive) −1.19 vs −1.16 points at week 52 (difference −0.03; 95% CI −0.18 to 0.12); QWINT-2 (n=928, vs degludec) −1.26 vs −1.17; QWINT-3 (n=986, basal-experienced) −0.81 vs −0.72 at week 26; QWINT-4 (n=730, basal-bolus) −1.01 vs −1.00. Level 2-3 hypoglycemia was lower with efsitora only in QWINT-1 (0.50 vs 0.88 events/patient-year).
Why it matters: glycemic control is equivalent, not superior, and the trials were open-label and manufacturer-funded; the gain is convenience and adherence, and for Dominican patients who rely on glargine or NPH the question will be price, not efficacy. No indication in type 1.
https://www.hcplive.com/view/insulin-efsitora-alfa-onswik-gains-fda-approval-for-type-2-diabetes
https://doi.org/10.1056/NEJMoa2502796

2. Finerenone, first therapy approved for chronic kidney disease associated with type 1 diabetes

[Regulatory FDA] [United States / Germany]
On September 17 the FDA extended the indication of finerenone (Kerendia, Bayer) to reducing albuminuria in adults with chronic kidney disease associated with type 1 diabetes, the first new treatment for this group in more than 30 years. FINE-ONE (phase 3, randomized, double-blind, n=242, finerenone 10-20 mg vs placebo on top of standard care) reduced the urine albumin-to-creatinine ratio by 22% at month 3 (ratio 0.78; 95% CI 0.68-0.90) and 28% at month 6 (0.72; 0.60-0.86). Hyperkalemia: 10.1% vs 3.3%; discontinuation for hyperkalemia 1.7% vs 0. Published in NEJM 2026;394:947-957.
Why it matters: it is the first type 1-specific evidence, but the endpoint is a marker (albuminuria), not hard kidney or cardiovascular events, and the trial was small and Bayer-funded; in practice it means monitoring potassium in patients who usually already take an ACE inhibitor or ARB.
https://www.hcplive.com/view/fda-approves-finerenone-kerendia-for-ckd-and-type-1-diabetes
https://doi.org/10.1056/NEJMoa2512854

3. ADA/EASD 2026 consensus on the management of type 1 diabetes in adults

[Guideline] [United States / Europe]
Diabetologia published online on September 16 the 2026 update of the ADA/EASD consensus on type 1 diabetes in adults (Holt, Peters et al.; 14 authors; literature review January 2021 to July 2025; the draft was presented at EASD Vienna 2025). Compared with the 2021 version, the document centers care on continuous glucose monitoring and automated insulin delivery as the standard, incorporates therapies that delay stage 3 (teplizumab), and adds sections on complication screening, obesity and cardiovascular risk in type 1, and psychosocial care and structured education. Open access, 54 pages.
Why it matters: it is the reference document for the coming years and sets as standard a technology that remains unevenly accessible in the Dominican Republic; read it as an expert consensus (not a guideline with formal evidence grading) and adapt its steps to each center's context.
https://link.springer.com/article/10.1007/s00125-026-06833-z

4. FDA clears the Mint insulin patch pump (Beta Bionics)

[Regulatory FDA] [United States]
On September 14 the FDA cleared (510(k)) the Mint patch pump: two pieces (reusable and disposable), 200-unit reservoir, 3-day wear plus a 12-hour grace period, no recharging, water-resistant (IPX8), smartphone control and integration with Dexcom G7, G7 15 Day and FreeStyle Libre 3 Plus. Launch planned for the first quarter of 2027, pharmacy channel only, in the United States. The "3D Intelligence" automated algorithm was submitted separately and remains pending.
Why it matters: it adds competition for Omnipod, but no comparative clinical data have been published and the clearance covers the device, not the closed-loop system; for our region the relevance is medium term.
https://www.hcplive.com/view/fda-clears-beta-bionics-mint-insulin-patch-pump-for-diabetes

5. Tirzepatide gains a cardiovascular indication in type 2 diabetes (SURPASS-CVOT)

[Regulatory FDA] [United States]
On August 28 the FDA approved tirzepatide (Mounjaro) to reduce major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or stroke) in adults with type 2 diabetes at high cardiovascular risk. SURPASS-CVOT (n=13,299, 640 sites in 30 countries, adults with type 2 diabetes and established atherosclerotic disease, tirzepatide 15 mg or maximum tolerated dose vs dulaglutide 1.5 mg weekly, median follow-up 210 weeks) met non-inferiority: HR 0.92 (95.3% CI 0.83-1.01), without demonstrating superiority. No new safety signals; the C-cell tumor warning is retained. Full data are presented at EASD Milan on September 30.
Why it matters: the comparator was an active drug with its own cardiovascular benefit, so the correct reading is "as safe and at least as protective as dulaglutide," not "superior"; the item is 32 days old and is included for its weight.
https://www.hcplive.com/view/tirzepatide-gets-fda-approval-to-cut-cardiovascular-risk-in-type-2-diabetes

6. EASD 2026 (Milan, September 28-October 2): what is being presented this week

[Meeting] [Italy]
The 62nd EASD Annual Meeting opened on September 28. Lilly presents (September 30 and October 1) the full TRIUMPH-2 data (retatrutide, GIP/GLP-1/glucagon triple agonist, in obesity with type 2 diabetes): mean weight loss of up to 20.8% (22.5 kg) and HbA1c reduction of up to 1.6 points at 80 weeks, efficacy estimand; ACHIEVE-4 (oral orforglipron vs insulin glargine, non-inferior for cardiovascular events: MACE-4 HR 0.84, 95% CI 0.59-1.20); and phase 2 eloralintide plus tirzepatide (17% vs 10% weight loss at 16 weeks). Novo Nordisk brings 44 abstracts: REIMAGINE 1-3 (CagriSema in type 2 diabetes), phase 2b zenagamtide (formerly amycretin) in type 2 diabetes, the real-world OCTANE study (switching from injectable semaglutide or tirzepatide to oral semaglutide) and COMPETE SWITCH CV.
Why it matters: almost all of these are company topline results not yet peer reviewed; none changes prescribing today, and none of these drugs, except tirzepatide and semaglutide, is available in the Caribbean.
https://www.prnewswire.com/news-releases/lilly-to-present-new-data-on-foundayo-retatrutide-and-eloratzp-at-easd-2026-as-it-strives-to-change-the-course-of-cardiometabolic-health-302878341.html
https://www.globenewswire.com/news-release/2026/09/16/3362854/0/en/novo-to-share-real-world-and-clinical-data-including-wegovy-pill-and-cardiometabolic-pipeline-progress-with-next-generation-amylin-treatments-at-easd-2026.html

Obesity and metabolism

7. Endocrine Society scientific statement: obesity should be treated (and studied) for health outcomes, not weight alone

[Guideline] [United States]
On September 9, coinciding with the launch of its Center on Obesity, the Endocrine Society published in Endocrine Reviews the scientific statement "Obesity science, research gaps, and opportunities in the new era of obesity medicines" (Jastreboff et al.; corresponding author Daniel Drucker). It sets six research priorities: the pathophysiology of body-fat regulation, why drug response varies between people, treatment targets beyond weight, how the body adapts to the drugs over time, health outcomes (treating vs not treating, weight-independent effects) and long-term safety. The Society announces a clinical practice guideline on obesity pharmacotherapy for 2027.
Why it matters: it is a roadmap for researchers and contains no new clinical recommendations, but it anticipates the framework by which incretin agonists will be judged in the coming years; for practices where they are prescribed for cosmetic reasons or without follow-up, the message is timely.
https://academic.oup.com/edrv/advance-article/doi/10.1210/endrev/bnag025/8786107
https://www.healio.com/news/endocrinology/20260910/scientific-statement-to-researchers-look-at-obesity-outcomes-beyond-weight-loss

8. China brings to Milan a phase 3 trial of a GLP-1/GIP dual agonist (HS-20094) and a semaglutide biosimilar

[Meeting] [China]
According to Chinese media reports of September 9 and 23, several Chinese companies are presenting home-grown molecules at EASD 2026. The most advanced: HS-20094 (Hansoh), a weekly GLP-1/GIP dual agonist, with the LIGHTEN trial (HS-20094-301: phase 3, 48 weeks, multicenter, double-blind, n=604 adults with obesity without diabetes, 33 sites in China, 1:1:1:1 randomization to 5, 10, 15 mg or placebo), whose March topline showed weight loss of up to 19.3% at week 48 and up to 97.2% of patients with ≥5%; oral presentation on October 1. Huadong Medicine shows a phase 3 trial of its semaglutide biosimilar HDM1702 in obesity without diabetes (44 weeks): −15.24% vs −16.27% with the originator, within the equivalence margin. Hengrui brings two phase 3 trials of its oral GLP-1 HRS-7535 in type 2 diabetes. (Source in Chinese.)
Why it matters: these are company data in an exclusively Chinese population, disseminated by promotional media and not yet published in peer-reviewed form; the relevant signal for the region is industrial, because Chinese semaglutide biosimilars could lower access costs in Latin America within two years.
https://www.sohu.com/a/1080117635_121124549
https://news.qq.com/rain/a/20260909A04ZM800

9. Argentina (ANMAT) approves semaglutide 7.2 mg weekly for obesity

[Regulatory ANMAT] [Argentina]
On September 22 ANMAT approved the 7.2 mg weekly maintenance dose of semaglutide (Wegovy, Novo Nordisk) for adults with obesity, with or without type 2 diabetes (previous maximum 2.4 mg; same device). Basis: STEP UP (n=1,407 adults with obesity without diabetes; mean weight loss of approximately 21% at 72 weeks, superior to 2.4 mg and placebo; about one third lost ≥25%) and STEP UP diabetes (n=514). Safety consistent with the known profile (gastrointestinal effects).
Why it matters: Argentina is ahead of much of the region in authorizing the high dose; the gain over 2.4 mg is about 4 percentage points of weight at the cost of more gastrointestinal effects, and the source is the company itself, with no link to the ANMAT disposition. The presentation is not yet registered in the Dominican Republic.
https://www.perfil.com/noticias/sociedad/anmat-aprobo-una-nueva-dosis-de-semaglutida-para-tratar-la-obesidad-en-adultos.phtml

10. Brazil: ANVISA registers 14 GLP-1 pens in 2026 after the semaglutide patent expired

[Regulatory ANVISA] [Brazil]
According to Folhapress (September 14), after the Ozempic patent expired in Brazil on March 20, 2026, ANVISA has registered 14 injectable pens for type 2 diabetes and obesity this year: 10 semaglutide products (Ozivy/EMS since May 26; Semavy, Owozy, Zempneo, Seemasun and Orsema on July 29; EMS and Germed generics in August; Yluméc on August 31), 3 liraglutide products (two EMS generics approved September 8) and a new tirzepatide presentation. Reference prices: Ozempic R$975-999; Ozivy R$452-498; generics must be at least 35% cheaper (R$293-323 estimated). (Source in Portuguese.)
Why it matters: it is the first large Latin American market with real semaglutide competition and serves as a price reference for the Caribbean; the drawback is the lack of published interchangeability data for most of these pens.
https://www.otempo.com.br/saude-e-bem-estar/2026/9/14/anvisa-aprova-12-novas-canetas-para-diabetes-e-obesidade-em-2026-confira-opcoes-e-precos

Thyroid, parathyroid and bone metabolism

A thin month for thyroid: we found no verifiable randomized trials or new guidelines within the window; the ATA annual meeting is in November.

11. Circulating osteoprotegerin as a marker of bone metastases in medullary thyroid cancer

[Publication] [United States]
MD Anderson (Houston; Theresa Guise's group) published on September 8 in Cell Reports Medicine a study with preclinical models of two RET mutations and tumor and blood samples from 81 patients with medullary thyroid carcinoma. Tumor expression and circulating levels of osteoprotegerin (OPG) were much higher in patients with bone metastases, and high OPG was associated with shorter overall survival; the work also explores the drug ONC201 in the animal models. Public (CPRIT, NCI) and institutional funding.
Why it matters: it is a single-center study with no sensitivity figures, area under the curve or cutoffs, and the authors themselves call for validation; interesting as a hypothesis for following a tumor in which calcitonin and CEA do not discriminate bone involvement.
https://www.eurekalert.org/news-releases/1143157

12. FDA approves zilurgisertib for fibrodysplasia ossificans progressiva from age 12

[Regulatory FDA] [United States]
On September 25 the FDA approved zilurgisertib (Atebrioz, Mirum; oral ALK2 inhibitor, 100 mg/day), the third therapy for fibrodysplasia ossificans progressiva. Basis: cohort 1 of the PROGRESS trial (phase 2, randomized, double-blind, n=63, 24 weeks, mean age 21). The prespecified primary endpoint (proportion with new heterotopic ossification lesions) was 3.1% vs 16.7% (P=0.0986, not significant); approval rested on the change in new heterotopic bone volume by whole-body CT: −3.2 cm³ vs +24.6 cm³ with placebo (nominal P=0.004). No discontinuations for adverse events; embryo-fetal toxicity warning.
Why it matters: relevant to those who follow rare bone metabolism, but with a failed primary endpoint and a small cohort; it is an ultra-rare disease approval, not a change for common osteoporosis.
https://www.hcplive.com/view/zilurgisertib-receives-fda-approval-for-fop-in-patients-12-and-older
https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-third-treatment-fibrodysplasia-ossificans-progressiva

Pituitary, adrenal and gonads

No verifiable regulatory news or phase 3 trials this month in pituitary or adrenal disease (the European approval of paltusotine for acromegaly was in April and falls outside the window).

13. Testosterone and atrial fibrillation: a U-shaped relationship according to an updated review

[Publication] [United States]
On September 1 the Journal of the Endocrine Society published a narrative review (Barua et al., Kansas City VA) on testosterone, replacement therapy and atrial fibrillation. It concludes that both low and high testosterone are associated with higher atrial fibrillation risk, with the lowest risk in the mid-normal range, and proposes a total testosterone target of 350-550 ng/dL on replacement therapy, with monitoring of hematocrit, blood pressure and rhythm, and preference for formulations with stable pharmacokinetics in at-risk patients. No external funding.
Why it matters: it is an interpretive review, not a meta-analysis, and the proposed range is inferred from observational data without any prospective trial; useful as a reminder not to overtreat in hypogonadism clinics, not as a new therapeutic target.
https://academic.oup.com/jes/article/10/9/bvag180/8772956

Cross-cutting

14. XVIII Central American and Caribbean Endocrinology Congress (Punta Cana, August 27-30)

[Meeting] [Dominican Republic]
SODENN organized the XVIII Central American and Caribbean Endocrinology Congress and the II Pediatric Endocrinology Symposium in Punta Cana on August 27-30, with Enrique Caballero (ADA) as guest and a program focused on cardio-renal-hepatic-metabolic health with GLP-1 and dual agonists, diabetes technology, MASLD, thyroid nodule ablation with ethanol and radiofrequency, osteoporosis and artificial intelligence applied to nutrition. The "Dr. Yulino Castillo" research prize was awarded for the first time.
Why it matters: it is the regional forum for the specialty; we could not locate published abstracts or results from the congress, so we record it as a completed agenda item rather than as evidence.
https://diariosalud.do/presente-y-futuro-de-la-endocrinologia-convergen-en-punta-cana-xviii-congreso-centroamericano-y-del-caribe-2026

Other regions: in Japan, Korea, India, Russia, the Middle East, Turkey and continental Europe we found no items this month with verifiable date and data within the window; nothing was included to avoid padding.

Upcoming meetings and dates

EASD 2026, Milan, through October 2 (presentations of SURPASS-CVOT, TRIUMPH-2, ACHIEVE-4, REIMAGINE and HS-20094 between September 29 and October 1). Endocrine Society and Keystone Symposia, "Hormonal Influences on Immunity and Cancer Across the Lifespan," Breckenridge, Colorado, October 5-8. ATA 2026, American Thyroid Association annual meeting, Philadelphia, November 4-7.

Monthly endocrinology bulletin — September 29, 2026
14 verified items from the past month: NEJM, Diabetologia, Endocrine Reviews, Cell Reports Medicine, Journal of the Endocrine Society, FDA, ANMAT and ANVISA, plus the opening of EASD 2026 in Milan.
Three worth your time:
• FDA approved once-weekly insulin efsitora alfa for type 2 diabetes: HbA1c non-inferior to glargine or degludec across 4 trials with more than 3,400 adults; open-label, company-funded trials, so the gain is convenience, not control.
• Finerenone is the first therapy approved for CKD associated with type 1 diabetes: UACR −28% at 6 months in FINE-ONE (n=242), hyperkalemia 10% vs 3%; the endpoint is a marker, not hard outcomes.
• Tirzepatide gained a cardiovascular indication with SURPASS-CVOT (n=13,299): HR 0.92 (0.83-1.01) vs dulaglutide; non-inferior, superiority not shown.
Full bulletin, with a critical reading of every study and links to the primary sources:
https://boletinesmedicos.com/en/endocrinologia/2026-09-29.html
#Endocrinology #Diabetes #Obesity #Insulin #EASD2026

Endocrinology, September 2026: FDA approves weekly insulin efsitora (HbA1c non-inferior in 4 phase 3 trials) and finerenone for CKD in type 1 diabetes (UACR −28%, n=242). Critical reading and sources: https://boletinesmedicos.com/en/endocrinologia/2026-09-29.html