Women’s Health Video Recap—January 21, 2026

This biweekly Women’s Health video roundup spans regulatory actions, late-stage clinical readouts, digital health rollouts, and practice guidance. Highlights include rare-disease approval, women’s health access changes, neurology and psychiatry data, and policy updates.

Watch Our Video Summary Capturing Top Women’s Health News from the Last Two Weeks

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Transcript

Welcome to the latest edition of Women’s Health Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.

First, the NEJM-published Phase 3 SPACE trial in children and adolescents with episodic migraine ran for 3 months with 237 participants ages 6–17. Ajovy, fremanezumab, reduced monthly migraine and headache days versus placebo and increased the proportion achieving at least 50 percent reduction, with a safety profile consistent with adults.

Ultrahuman, in partnership with Click Therapeutics, announced the Migraine PowerPlug for its smart ring, integrating FDA-authorized digital therapeutics content. It analyzes HRV, sleep, movement, and stress signals to flag precursors to attacks and then delivers guided behavioral interventions, with rollout planned for early 2026 in major markets.

At ACNP, pooled Phase 3 Studies 501 and 502, plus the 6-month open-label Study 503, showed that adjunctive Caplyta, lumateperone, nearly doubled 6-week remission versus placebo and maintained high, sustained remission over 24 weeks in the open-label setting.

Also, an observational study in the European Journal of Neurology followed 719 people with early multiple sclerosis for 3 years. A Random Forest model predicted progression independent of relapse activity with an AUC around 0.75 overall, reaching about 0.80 in selected subsets, with key predictors including age at onset and early disability scores.

The FDA approved Zycubo, copper histidinate, a subcutaneous formulation with Breakthrough, Fast Track, Orphan, and Rare Pediatric Disease designations, as the first US therapy for Menkes disease. An early treatment cohort showed a significant overall survival benefit versus contemporaneous external controls, and common adverse events are described in the label.

Analyses in Science Translational Medicine of samples from CAPELLA and CALIBRATE reported that capsid mutations, notably M66I, can confer resistance to lenacapavir yet reduce replication capacity, supporting combination therapy and resistance monitoring.

The MHRA affirmed that paracetamol remains first-line for pain and fever in pregnancy when used as directed, citing a Lancet O&G umbrella review finding no link to autism, ADHD, or intellectual disability, and it encouraged routine advice and Yellow Card reporting.

Updated international guidance on endometriosis, aligned with WHO priorities, called for symptom-led recognition, earlier referral, multidisciplinary management, and proactive fertility counseling to close persistent diagnostic and care gaps.

Finally, the FDA extended Nexplanon implant duration from 3 to 5 years and added a REMS to certify inserters. In the extended-use US trial there were no pregnancies in years 4 to 5, and labeling supports use across a wide BMI range with enhanced training and controlled distribution.

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Why It Matters

Pediatric migraine now has CGRP prevention evidence and labeling continuity from adults, potentially reducing school impact and caregiver burden [1].
Wearables plus FDA-authorized DTx point to a practical pathway for earlier migraine interventions at scale [2].
Remission-focused outcomes in MDD may reset treatment expectations beyond response metrics [3].
Early MS risk-stratification for PIRA could guide initial therapy intensity and monitoring plans [4].
First approved Menkes therapy changes the US standard for a previously untreatable fatal disorder [5].

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FAQ

What did the SPACE trial show for Ajovy in pediatric episodic migraine?

Ajovy reduced monthly migraine and headache days versus placebo over 12 weeks, with higher ≥50% responder rates and no new safety signals, in 6–17-year-olds (N=237) [1].

How will Ultrahuman’s Migraine PowerPlug work with the ring?

It analyzes HRV, sleep, movement and stress deviations to flag potential precursors and delivers tailored behavioral interventions using Click Therapeutics’ FDA-authorized DTx content [2].

Does adjunctive Caplyta meaningfully improve remission in MDD?

In pooled Phase 3, lumateperone nearly doubled 6-week remission vs placebo, with durable remission observed over 6 months in open-label data; endpoints and definitions were MADRS-based [3].

Can clinicians predict early PIRA in MS without MRI?

An ML model using routine clinical variables achieved AUC ~0.75 overall, up to 0.80 in selected subgroups, suggesting feasible early risk-stratification in practice settings [4].

What changed with Nexplanon’s US label?

FDA extended duration of use to 5 years with no pregnancies in years 4–5 in the US trial and introduced a REMS to mitigate insertion/removal complications, applicable across a wide BMI range [9].

Is paracetamol safe in pregnancy per UK regulators?

Yes, MHRA reaffirmed paracetamol as first-line for pain and fever during pregnancy when taken as directed, based on a new large-scale analysis showing no link to neurodevelopmental disorders [7].

Entities / Keywords

Ajovy, fremanezumab, CGRP; Ultrahuman Ring Air, Click Therapeutics, digital therapeutics; Caplyta, lumateperone, MDD, MADRS; multiple sclerosis, PIRA, Random Forest; Zycubo, copper histidinate, Menkes disease; lenacapavir, Yeztugo, Sunlenca, HIV capsid; MHRA, paracetamol in pregnancy; endometriosis guidance, WHO; Nexplanon, etonogestrel implant, REMS.