Upadacitinib hemihydrate

Cosmo Pharmaceuticals plans regulatory submissions in both the US and Europe after reporting topline results from two successful Phase III trials of clascoterone 5% topical solution for male pattern hair baldness, news that sent company shares up 24% in Zurich on Wednesday.The studies — Scalp 1 and Scalp 2 — each met their primary endpoints, positioning Cosmo to move forward with the filings once the 12-month safety follow-up is completed in spring of 2026. Oddo BHF analysts estimate the potential market opportunity could reach several billion dollars.Clascoterone is a topical androgen-receptor inhibitor designed to block dihydrotestosterone directly at the hair-follicle receptor while minimising systemic hormonal exposure, a key limitation of currently available therapies. This localised mechanism "opens the door to a fundamentally better treatment paradigm for patients," CEO Giovanni Di Napoli said, noting that the company's internal market research suggests there is "enormous, underserved demand."The two identically designed trials enrolled a combined 1465 men in the US and Europe, making them the largest Phase III programme ever run for a topical therapy in male androgenetic alopecia, according to the company. In Scalp 1, clascoterone achieved a 539% relative improvement in Target-Area Hair Count (TAHC) versus vehicle, while Scalp 2 delivered a 168% relative improvement.Cosmo said these gains were reflected in patient-reported outcomes (PRO) as well. One trial met its PRO endpoint and the other trended positively; combined analysis across both studies was statistically significant, indicating participants not only grew more hair, but also perceived meaningful improvement.On the safety-front, Cosmo said rates of treatment-emergent adverse events were similar to vehicle in both studies, with most adverse events deemed unrelated to treatment.Clascoterone was approved by the FDA in 2020 as Winlevi to treat acne vulgaris in people aged 12 and older. Several companies are advancing alopecia treatments. AbbVie said in August that it was planning regulatory submissions for Rinvoq (upadacitinib) to treat hair loss after roughly 44% to 55% of patients on the JAK inhibitor achieved at least 80% scalp hair coverage (SALT score ≤20) at week 24 across a pair of Phase III studies.The hair-loss space has also drawn investor interest. Pelage Pharmaceuticals recently closed a $120-million series B round to advance a regenerative medicine approach that targets dormant stem cells in hair follicles, while Veradermics clinched a $150-million series C to fund ongoing Phase III studies evaluating its non-hormonal, oral treatment for hair loss in both men and women.

WEDNESDAY, Nov. 26, 2025 -- Early use of higher-efficacy therapies is recommended for patients with moderately to severely active Crohn disease (CD), according to a living clinical practice guideline issued by the American Gastroenterology Association (AGA) and published online Nov. 20 in Gastroenterology . Frank I. Scott, M.D., from the University of Colorado Anschutz School of Medicine in Aurora, and colleagues developed a living guideline to support practitioners in the pharmacologic management of moderately to severely active CD. The panel agreed on 16 recommendations: one strong and nine conditional; six were identified as knowledge gaps. The AGA recommends use of infliximab, adalimumab , ustekinumab, risankizumab, mirikizumab, guselkumab, or upadacitinib over no treatment in adults with moderately to severely active CD; use of certolizumab pegol or vedolizumab is suggested over no treatment. The AGA suggests using higher-efficacy medication rather than lower-efficacy medication (infliximab, adalimumab, vedolizumab, ustekinumab, risankizumab, mirikizumab, or guselkumab versus certolizumab pegol or upadacitinib) for individuals who are naive to advanced therapies. A higher-efficacy medication or intermediate-efficacy medication is suggested rather than a lower-efficacy medication (adalimumab, risankizumab, guselkumab, upadacitinib, ustekinumab, or mirikizumab versus vedolizumab or certolizumab pegol) for individuals who have been exposed to one or more advanced therapies. The AGA suggests against using thiopurine monotherapy for induction of remission in adult outpatients with moderately to severely active CD; thiopurine monotherapy is suggested over no treatment for maintenance of remission, typically induced by corticosteroids. Initial advanced therapy is suggested over step therapy involving corticosteroids and/or immunomodulators. "Patients should recognize that there are now multiple treatment options available to them, regardless of where they are in their treatment journey," Scott said in a statement. Abstract/Full Text