Endocrinology Weekly Update – September 29th 2025

LucidQuest

1 month ago

Endocrinology Update: Once-Weekly Kyinsu, Bayer’s Lynkuet, EASD’s clinical guideline and More

From CHMP backing of Novo Nordisk’s once-weekly Kyinsu (icodec/semaglutide) for type 2 diabetes and Bayer’s Lynkuet (elinzanetant) for vasomotor symptoms to Baricitinib’s C-peptide preservation in new-onset T1D, this update spans diabetes advancements and menopause therapies. It also includes the first EASD clinical guideline on diabetes distress, new insights linking parathyroidectomy with reduced diabetes risk, rising thyroid cancer rates in Taiwan, and approvals of novel biosimilars and oral SST2 agonists—shaping the evolving landscape of endocrinology and metabolic disease.

In Today’s Newsletter

💉 CHMP backs Novo’s once-weekly Kyinsu (icodec/semaglutide) for T2D [1] [EU • 22 Sep 2025]

https://www.europeanpharmaceuticalreview.com/news/265705/novo-nordisks-once-weekly-diabetes-jab-kyinsu-set-for-european-approval/
Context: Context: Combo insulin icodec + semaglutide; pre-filled pen (700 U/mL / 2 mg/mL). Three Phase 3s supported benefit (details not specified).
Key point: Positive CHMP opinion for adults with T2D inadequately controlled on basal insulin or GLP-1 RAs (endpoint not specified).
Implication: Introduces competition that may affect pricing and formulary access.

🌡️ CHMP positive for Bayer’s Lynkuet (elinzanetant) for vasomotor symptoms [1] [EU • 22 Sep 2025]

https://www.europeanpharmaceuticalreview.com/news/265705/novo-nordisks-once-weekly-diabetes-jab-kyinsu-set-for-european-approval/
Context: Non-hormonal NK-1/NK-3 antagonist; 60 mg capsule; Phase 3s showed fewer moderate–severe hot flushes and better sleep/QoL.
Key point: CHMP recommends approval for moderate–severe vasomotor symptoms (endpoint not specified).
Implication: Introduces competition that may affect pricing and formulary access.

🔬 Baricitinib preserves C-peptide in new-onset T1D (BANDIT) [2] [22 Sep 2025]

https://www.healio.com/news/endocrinology/20250922/baricitinib-preserves-cpeptide-in-patients-with-type-1-diabetes
Context: EASD-presented RCT (n=91; ages 10–30); 4 mg daily ×48 wks vs placebo; effects diminished after discontinuation.
Key point: During treatment, higher C-peptide, lower insulin dose, improved variability/TIR; HbA1c similar overall.
Implication: May influence prescriber choice and payer reviews pending full data.

🧠 EASD’s first clinical guideline on diabetes distress [3] [EU • 22 Sep 2025]

https://pharmacyupdate.online/2025/09/easd-launches-its-first-ever-clinical-practice-guideline-the-worlds-first-to-focus-on-diabetes-distress/
Context: GRADE/RIGHT methods; lived-experience panel; focus on routine assessment + psychological/psychoeducational interventions.
Key point: Recommends systematic screening and structured support; acknowledges research gaps.
Implication: May expand screening, initiation, and follow-up at scale.

🧮 Parathyroidectomy tied to ~30% lower diabetes risk in PHPT (HKUMed) [4] [Hong Kong • 22 Sep 2025]

https://www.hku.hk/press/press-releases/detail/28611.html
Context: Territory-wide EHR cohort (>3,100; 2006–2023); median follow-up ~3 years; observational analysis.
Key point: Surgery associated with ~30% lower new-onset diabetes risk; effect stronger in younger/more severe PHPT.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🧵 Thyroid cancer in Taiwan: 4th most common in women; cases rising [5] [Taiwan • 24 Sep 2025]

https://www.taiwannews.com.tw/news/6206782
Context: 5,601 new cases in 2022 (~+1,000 vs 2021); ~3× higher in women; onset ~50 yrs.
Key point: Emphasizes symptoms, ultrasound + FNA diagnosis, surgery and radioiodine; targeted therapy if recurrent/metastatic.
Implication: May expand screening, initiation, and follow-up at scale.

🌟 “North Star” DTE hits Phase 2 primary endpoint in hypothyroidism [6] [24 Sep 2025]

https://pharmatimes.com/news/north-star-shows-promise-in-phase-2-thyroid-trial/
Context: Acella/Neuvosyn desiccated thyroid extract; dose-conversion vs levothyroxine defined; safety favorable (topline).
Key point: Positive Phase 2 supports path toward FDA review (endpoint specifics beyond conversion not stated).
Implication: May influence prescriber choice and payer reviews pending full data.

🦴 CHMP positive for denosumab biosimilar AVT03 (Prolia/Xgeva) [6] [EU • 24 Sep 2025]

https://www.indianpharmapost.com/news/lite/dr-reddys-receives-positive-chmp-opinion-from-ema-for-denosumab-avt03-17865
Context: Dr. Reddy’s (registration/commercialization) & Alvotech (development/manufacturing); EU EC decision pending; UK via IRP planned.
Key point: Positive opinion across Prolia/Xgeva indications; tradenames Acvybra (60 mg/mL PFS) and Xbonzy (70 mg/mL vial) upon approval.
Implication: Introduces competition that may affect pricing and formulary access.

🍁 Health Canada approves Celltrion’s STOBOCLO/OSENVELT (denosumab) [7] [Canada • 25 Sep 2025]

https://www.kedglobal.com/biotech-amp-healthcare/newsView/ked202509250002
Context: Biosimilars to Prolia/Xgeva; approvals follow prior KR/EU/US nods; Canada market ~US$180M (per report).
Key point: Full-label approvals for postmenopausal osteoporosis and oncology bone complications/GCTB.
Implication: Introduces competition that may affect pricing and formulary access.

🟣 FDA approves PALSONIFY (paltusotine) for acromegaly — first oral, once-daily SST2 agonist [8] [US • 25 Sep 2025]

https://crinetics.com/crinetics-announces-fda-approval-of-palsonify-paltusotine-for-the-treatment-of-acromegaly-in-adults/
Context: Based on PATHFNDR-1/-2 Phase 3 trials; OLE data at ENDO 2025; generally well-tolerated.
Key point: Approved for adults with inadequate surgical response or not surgical candidates; reported durable IGF-1 and symptom control.
Implication: May influence prescriber choice and payer reviews pending full data.

❤️‍🩹 GLP-1 RAs linked to lower CV/renal events vs DPP-4s in SLE + T2D (observational) [9] [26 Sep 2025]

https://www.medpagetoday.com/rheumatology/lupus/117674
Context: TriNetX target-trial emulation; GLP-1 (n=910) vs DPP-4 (n=1,004); follow-up 1.3–3.0 yrs; hazard ratios favored GLP-1s for MACE, VTE, renal progression, mortality.
Key point: Association suggests cardio-renal benefit; mechanisms beyond weight/glucose posited; residual confounding possible.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🧬 PCOS independently increases long-term T2D risk (Fertility & Sterility) [10] [29 Sep 2025]

https://medicaldialogues.in/diabetes-endocrinology/news/pcos-may-increase-risk-of-type-2-diabetes-finds-study-156034
Context: US EHR study (2000–2020); 42,030 PCOS vs matched controls (age/ethnicity/geo ± BMI).
Key point: Adjusted HR ~1.47 for T2D; elevated risk across BMI classes (HR ~1.37–1.78); higher BMI adds further risk.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

Why it matters

Oral endocrine options (paltusotine) can reduce injection burden and broaden access in acromegaly.
Denosumab biosimilar momentum (EU, Canada) pressures originator pricing and expands formulary flexibility.
Immune-metabolic cross-talk: GLP-1 signals benefits in complex SLE + T2D populations; baricitinib hints at beta-cell preservation in early T1D.
Psychosocial care is moving center stage in diabetes via EASD’s first guideline.
Surgical correction of PHPT may yield metabolic dividends; PCOS confers BMI-independent T2D risk, underscoring early prevention.

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FAQ

What is Kyinsu and who might receive it?

Kyinsu combines insulin icodec + semaglutide as a once-weekly injection for adults with T2D not controlled on basal insulin or GLP-1 RAs; CHMP issued a positive opinion (endpoint specifics not stated) [1].

How strong is the evidence for baricitinib in new-onset T1D?

BANDIT (n=91) showed preserved C-peptide and lower insulin dose during 48-week therapy with improvements in variability/TIR; benefits waned after stopping; HbA1c overall similar [2].

What’s new in menopause VMS treatment?

Bayer’s non-hormonal elinzanetant (Lynkuet) received a CHMP positive opinion after Phase 3s reduced hot-flush frequency and improved sleep/QoL [1].

What changed for acromegaly care?

FDA approved once-daily oral paltusotine (PALSONIFY) for adults not cured by or unsuitable for surgery, supported by two Phase 3 trials and OLE data [8].

Are lower-cost denosumab options arriving?

Yes. AVT03 received a CHMP positive opinion in Europe [6], and Celltrion gained Health Canada approvals for STOBOCLO/OSENVELT with full labels [7].

Does PCOS raise diabetes risk independent of weight?

Yes. A large US EHR study reported ~50% higher T2D risk in PCOS vs controls, persisting across BMI strata; higher BMI adds further risk [10].

Entities / Keywords

Kyinsu; insulin icodec; semaglutide; Novo Nordisk | Lynkuet; elinzanetant; Bayer | Baricitinib (Olumiant); BANDIT; EASD | Diabetes distress guideline; GRADE; RIGHT | Primary hyperparathyroidism; parathyroidectomy; HKUMed | Thyroid cancer; Taiwan | Desiccated thyroid extract; North Star; Acella; Neuvosyn | Denosumab; AVT03; Prolia; Xgeva; Dr. Reddy’s; Alvotech | STOBOCLO; OSENVELT; Celltrion; Health Canada | Paltusotine; PALSONIFY; Crinetics; SST2 agonist | GLP-1 receptor agonists; DPP-4 inhibitors; SLE; lupus nephritis | PCOS; Fertility & Sterility; T2D