Endocrinology Video Recap—November 4, 2025

LucidQuest

2 months ago

In this endocrinology video reacap , we review the most recent news: regulatory updates, promising results from the pipeline, and technology breakthroughs influencing the future of care

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Week 21–28 October 2025
Week 28 October–4 November 2025

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Transcript

Welcome to the latest edition of Endocrinology Updates, covering the latest breakthroughs. Brought to you by LucidQuest, this update highlights:

On World Osteoporosis Day, Sōlaria Biō introduced Bondia, a synbiotic medical food. The company cites a randomized, placebo-controlled study in Osteoporosis International with 286 participants. In postmenopausal women with osteopenia or BMI at least 30, Bondia reportedly slowed bone loss, including an 85 percent femoral-neck reduction versus placebo. Fracture outcomes were not reported.
The FDA added a cardiovascular risk-reduction indication to Rybelsus, oral semaglutide, supported by the Soul phase 3b trial showing a 14 percent relative risk reduction in MACE versus placebo.

Tzield, teplizumab, entered expedited FDA review through a new pilot program for stage 3 disease in recently diagnosed children and adolescents. Protect reported preservation of C-peptide, while key secondary endpoints were not statistically significant. Timelines may shorten, exact action dates were not provided.

Lilly and Cipla will distribute Yurpeak, a second brand of tirzepatide. Pricing will mirror Mounjaro, with 2.5 to 15 milligram KwikPen strengths, aiming to reach beyond major cities.

Nice will adapt the Monash-led 2023 International PCOS Guideline, localizing 254 recommendations and practice points for UK services. Specific UK modifications are not detailed.

The FDA granted interchangeability to Fresenius Kabi’s denosumab-bnht, Conexxence and Bomyntra, referencing Prolia and Xgeva. REMS and boxed warnings apply. Interchangeability enables pharmacy substitution per state law .

Tirzepatide, as Mounjaro and Zepbound, led 2025 year-to-date global medicine sales, with 10.1 billion dollars in Q3 and 24.8 billion dollars year to date, surpassing Keytruda at 23.3 billion dollars.

The FDA granted interchangeability to Celltrion’s denosumab-bmwo, Stoboclo and Osenvelt, across all approved indications, allowing pharmacy substitution per state law .

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🗓️ Explore weekly details and sources

Week 21–28 October 2025
Week 28 October–4 November 2025

📚 See the full Endocrinology archive on our research hub page.

Why it matters

Dual sponsor interchangeability for denosumab may accelerate payer adoption and pharmacy substitution in osteoporosis and oncology bone indications.

Oral semaglutide’s CV label expansion broadens GLP-1 use in cardiometabolic care.

Expedited regulatory pathways for T1D immunotherapy could shift earlier intervention standards.

India distribution partnerships can scale access for incretin therapies beyond major metros.

FAQ

What did the SOUL study show for Rybelsus?

Per the source, SOUL reported a 14% relative risk reduction in MACE vs placebo in adults with T2D at high CV risk, supporting FDA’s label expansion for oral semaglutide [2].

How does the FDA’s expedited review affect Tzield timelines?

The sBLA entered a pilot that shortens review using a collaborative process. Exact FDA action dates are not provided in the source, but the program is described as faster than standard review.

What is Yurpeak and how does it differ from Mounjaro in India?

Yurpeak is a second tirzepatide brand distributed and promoted by Cipla, with Lilly manufacturing. Pricing will match Mounjaro and offer 2.5–15 mg KwikPen strengths to widen reach beyond cities.

Which denosumab biosimilars received US interchangeability?

Fresenius Kabi’s Conexxence and Bomyntra (denosumab-bnht) and Celltrion’s STOBOCLO and OSENVELT (denosumab-bmwo) are interchangeable with Prolia/Xgeva for their approved indications, allowing pharmacy substitution per state law.

Did Bondia prove fracture reduction?

The company reports slowing of bone loss and femoral-neck benefit vs placebo in postmenopausal women. Fracture outcomes are not stated in the provided summary and would require full study details.

Entities / Keywords

Sōlaria Biō Bondia; synbiotic medical food; bone mineral density; Novo Nordisk Rybelsus oral semaglutide; SOUL trial; Sanofi Tzield teplizumab; PROTECT; Lilly; Cipla; Yurpeak tirzepatide; Mounjaro; Zepbound; NICE; Monash PCOS Guideline; Fresenius Kabi Conexxence Bomyntra denosumab-bnht; Celltrion STOBOCLO OSENVELT denosumab-bmwo; Prolia; Xgeva; cardiometabolic; interchangeability.

References

https://www.biospace.com/press-releases/solaria-bio-announces-new-bone-health-breakthrough-with-bondia
https://www.zacks.com/stock/news/2773041/nvos-rybelsus-gets-fda-nod-to-reduce-heart-risk-in-diabetes-patients
https://www.managedhealthcareexecutive.com/view/type-1-diabetes-drug-tzield-under-expedited-review-through-new-fda-program
https://www.business-standard.com/industry/news/lilly-cipla-yurpeak-tirzepatide-launch-india-diabetes-obesity-125102301152_1.html
https://www.miragenews.com/nice-to-adapt-monash-led-pcos-guideline-for-uk-1558620/
https://www.businesswire.com/news/home/20251028528458/en/FDA-Grants-Interchangeable-Designation-to-Fresenius-Kabis-Biosimilars-Conexxence-and-Bomyntra-denosumab-bnht
https://www.statnews.com/2025/10/30/eli-lilly-zepbound-mounjaro-bestselling-obesity-drug/
https://www.prnewswire.com/news-releases/us-fda-grants-interchangeability-designation-to-celltrions-denosumab-biosimilars-stoboclo-denosumab-bmwo-and-osenvelt-denosumab-bmwo-302599537.html