Endocrinology Today—January 20, 2026

This week’s Endocrinology roundup covers regulatory actions in Europe, mid-stage clinical progress, real-world market shifts, and emerging tools in risk detection and biomaterials. Updates span diabetes, obesity, acromegaly, bone health, and AI-enabled screening.

In Today’s Newsletter

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🧬 MAR002 Phase 1 signals in acromegaly, MAR001 2026 catalysts [1] [US • 13 Jan 2026]

https://www.businesswire.com/news/home/20260113087728/en/Marea-Therapeutics-Unveils-Positive-Topline-Phase-1-Data-for-MAR002-in-Acromegaly-Demonstrates-Potential-for-Best-in-Disease-Efficacy-and-Dosing-Profile
Context: First-in-human, randomized, blinded, placebo-controlled Phase 1 in healthy males.
Key point: MAR002, an allosteric GHR mAb, produced robust, durable IGF-1 reductions with favorable safety, supporting biweekly to monthly dosing; Phase 2/3 initiation targeted mid-2026.
Implication: May influence prescriber choice and payer reviews pending full data.

💉 EC approves Ondibta (insulin glargine) biosimilar [2] [EU • 14 Jan 2026]

https://www.sandoz.com/sandoz-confirms-european-commission-approval-ondibtar-insulin-glargine-strengthening-overall/
Context: Developed by Gan & Lee, commercialized by Sandoz across Europe and other territories.
Key point: Approval across all Lantus SoloStar indications, with launch expected by early 2027.
Implication: Introduces competition that may affect pricing and formulary access.

🤝 B-FLEXION to acquire remaining 57% of Radius Health [3] [US • 12 Jan 2026]

https://www.prnewswire.com/news-releases/b-flexion-life-sciences-to-acquire-remaining-57-interest-in-radius-health-302658260.html
Context: Follows 2022 take-private with Patient Square; closing targeted by end of Q1 2026.
Key point: Consolidation centers on TYMLOS commercialization momentum.
Implication: Signals pipeline investment and modality expansion.

🦴 Angitia doses first patient in Phase 2 IDUN (AGA2115) for OI [4] [US • 12 Jan 2026]

https://www.globenewswire.com/news-release/2026/01/12/3216764/0/en/Angitia-Biopharmaceuticals-Announces-Dosing-of-First-Participant-in-Phase-2-IDUN-Trial-of-AGA2115-for-the-Treatment-of-Osteogenesis-Imperfecta.html
Context: Randomized, double-blind, placebo-controlled Phase 2 in adults with OI, primary analysis at Month 12.
Key point: AGA2115, a bispecific targeting DKK1 and sclerostin, moves into mid-stage testing after first-in-human BMD gains presented at ASBMR 2025.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Biomaterials study supports stem-cell islet delivery without immunosuppression [5] [12 Jan 2026]

https://www.prnewswire.com/news-releases/newcelx-announce-positive-results-from-international-collaborative-study-exploring-advanced-biomaterial-approaches-for-stem-cellderived-islet-delivery-in-type-1-diabetes-without-immune-suppression-302658361.html
Context: Collaborative work published in Diabetology evaluated ECM-integrated scaffolds for encapsulated PSC-derived islets.
Key point: ECM incorporation supported implanted islet function comparable to non-scaffold encapsulation, suggesting retrievable delivery potential.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🛡️ EU approves Teizeild (teplizumab) for stage 2 T1D delay [6] [EU • 12 Jan 2026]

https://finance.yahoo.com/news/press-release-sanofi-teizeild-approved-060000046.html
Context: Based on TN-10 Phase 2 showing delayed progression to stage 3 T1D; safety consistent with prior studies.
Key point: First disease-modifying T1D therapy approved in EU for adults and children ≥8 years with stage 2 T1D.
Implication: May influence prescriber choice and payer reviews pending full data.

📈 Mounjaro overtakes Wegovy in Korea prescriptions [7] [KR • 12 Jan 2026]

https://www.koreabiomed.com/news/articleViewAmp.html?idxno=30263
Context: HIRA data show rapid uptake after Aug 2023 launch, with higher-dose options added in late September.
Key point: November prescriptions for Mounjaro reached 97,344, surpassing Wegovy’s 71,333, amid rising GLP-1 market volume.
Implication: Introduces competition that may affect pricing and formulary access.

🫀 DiaCardia AI flags prediabetes from ECG alone [8] [JP • 19 Jan 2026]

https://www.isct.ac.jp/en/news/sx2binkwhkpc
Context: Science Tokyo team, model based on LightGBM, trained on 16,766 health checkup records; external validation performed.
Key point: AUROC 0.851 using 12-lead ECG only, with comparable single-lead performance and physiologically plausible features.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🧫 44-metabolite signature improves T2D risk prediction [9] [19 Jan 2026]

https://medicaldialogues.in/amp/mdtv/diabetes-endocrinology/videos/groundbreaking-metabolomic-signature-enhances-type-2-diabetes-risk-prediction-model-study-162926
Context: Nature Medicine analysis of 23,634 adults across 10 cohorts, up to 26 years follow-up.
Key point: Identified 235 metabolites linked to future T2D risk and a 44-metabolite panel outperforming traditional scores.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

Why it matters

EU approvals for teplizumab and insulin glargine reshape prevention and access in diabetes.
GLP-1 competition intensifies in Korea, signaling broader pricing and access shifts.
Early-signal platforms, from ECG-based AI to metabolomics, may scale risk detection.
Bone-health innovation advances with AGA2115 mid-stage OI trial and Radius ownership consolidation.
Biomaterial strategies could make islet therapies retrievable and immunosuppression-free.

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FAQ

What did Marea show with MAR002 in acromegaly?

Phase 1 in healthy volunteers showed dose-dependent IGF-1 reductions with favorable safety, supporting infrequent dosing and a Phase 2/3 start in mid-2026 [1].

When will Sandoz’s Ondibta launch in Europe?

Post-EC approval, Sandoz expects a launch by early 2027, covering all Lantus SoloStar indications [2].

What changes at Radius Health after the B-FLEXION deal?

B-FLEXION will own 100% post-close, reinforcing TYMLOS commercialization and operational focus; closing targeted by end of Q1 2026 [3].

What is Angitia’s IDUN trial testing?

AGA2115, a DKK1/sclerostin-targeting bispecific, in adult OI. Primary endpoint is 12-month lumbar spine BMD percent change, with an open-label extension [4].

How did teplizumab perform for stage 2 T1D in the EU decision?

EU approval relied on TN-10 Phase 2 showing delayed progression to stage 3 T1D; safety aligned with prior experience [6].

How strong is the evidence behind DiaCardia and the metabolomics signature?

DiaCardia achieved AUROC 0.851 internally with external validation using ECG alone [8]. The metabolomics study associated 235 metabolites with future T2D and proposed a 44-metabolite panel that improved prediction in long-term cohorts [9].

Entities / Keywords

Marea Therapeutics; MAR002; growth hormone receptor; IGF-1; MAR001; ANGPTL4 • Sandoz; Ondibta; insulin glargine; Lantus biosimilar • Radius Health; B-FLEXION; TYMLOS; abaloparatide • Angitia Biopharmaceuticals; AGA2115; osteogenesis imperfecta; DKK1; sclerostin • NewcelX; stem cell-derived islets; extracellular matrix; encapsulation • Sanofi; Teizeild; teplizumab; stage 2 type 1 diabetes • Eli Lilly; tirzepatide; Mounjaro; Wegovy; semaglutide; HIRA • Science Tokyo; DiaCardia; ECG; LightGBM • Mass General Brigham; Albert Einstein College of Medicine; Nature Medicine; metabolomics; risk prediction.