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Cures For Hair Loss 2023 - News Feed
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Samson Clinical Completes Enrollment for Phase 3 Trial of Sublingual Minoxidil in Androgenic Alopecia
Samson Clinical has completed enrollment for its Phase 3 trial evaluating sublingual minoxidil as a potential new treatment for androgenic alopecia (AGA). The 24-week, placebo-controlled study will assess safety and efficacy in men with AGA, with results expected in mid-2026. Rapid recruitment highlights strong demand for effective, libido-neutral hair loss treatments without serious safety warnings.
Pelage Pharma has Announced $120 million in Funding to Advance Androgenic Alopecia Treatment PP405 into Phase 3
Pelage Pharmaceuticals has raised $120 million in a Series B round to advance PP405, a first-in-class topical therapy that reactivates dormant hair follicle stem cells. Positive Phase 2a safety results and early signs of hair regrowth support the company’s plan to begin Phase 3 trials in 2026. The financing also brings new board leadership as Pelage moves toward developing a regenerative, non-invasive treatment for androgenic alopecia.
Veradermics has Announced Significant Funding to Advance Androgenic Alopecia Treatment Through Phase 3 Trials
Veradermics has raised an oversubscribed $150 million Series C round to advance VDPHL01, its extended-release oral minoxidil candidate, through multiple Phase 3 trials and toward an FDA submission as a potential first-in-class treatment for pattern hair loss. Early Phase 2 data in men show rapid, visible hair regrowth with a favorable safety profile. The funding will support continued clinical development for a condition affecting an estimated 80 million people in the U.S.
Sun Pharma Announces the Launch of Leqselvi for Alopecia Areata
After months of waiting under an injunction, Sun Pharma has recently announced that they have launched their alopecia areata treatment Leqselvi (deuruxolitinib) for alopecia areata in the United States.
Sun Pharma Injunction for Alopecia Areata Treatment Lifted
After a lengthy injunction by Incyte against Sun Pharma's deuruxolitinib (Leqselvi), Sun Pharma has received the all-clear to release their alopecia areata treatment. In July 2024, Leqselvi received FDA clearance for the treatment of adults with severe alopecia areata.
Incyte had alleged in November 2024, that Leqselvi, a deuterated version of Incyte's ruxolitinib, violated patent 335, which covers the use of the drug to treat immune-related diseases, skin disorders, myeloid proliferative disorders, and cancer. Sun Pharma will announce launch plans in due course.
Q32 Bio To Present Late-Breaking Results from the SIGNAL-AA Trial for Alopecia Areata
Q32 Bio, a clinical-stage biotechnology company focused on developing biologic therapeutics for autoimmune diseases, has announced that results from Part A of its Phase 2a SIGNAL-AA trial evaluating bempikibart in patients with alopecia areata (AA) will be presented as a late-breaking oral session at the 2025 American Academy of Dermatology (AAD) Annual Meeting.
Bempikibart (ADX-914) is a fully human anti-IL-7Rα antibody designed to re-regulate adaptive immune function by blocking IL-7 and TSLP signaling. The IL-6 and TSLP pathways have been implicated in driving T cell-mediated pathology in various autoimmune diseases, including AA.
The SIGNAL-AA study is a randomized, placebo-controlled Phase 2a trial evaluating bempikibart in patients with severe and very severe alopecia areata. The results to be presented at AAD 2025 will offer new insights into its efficacy and safety profile.
According to Q32 Bio, bempikibart demonstrated promising clinical activity and was well-tolerated. While the press release did not provide actual efficacy data, the selection of the study for an oral late-breaking presentation suggests that the findings could be significant. The company states that the results support bempikibart's potential as a transformative treatment for alopecia areata.
The presentation will take place on Saturday March 8th, 2025, from 10:36 am to 10:48 am ET.
Olix Pharma Shows Safety in Phase 1 Trial for Androgenic Alopecia with OLX72021
Olix Pharmaceuticals has conducted a Phase 1 safety study in Australia for their androgenic alopecia treatment OLX72021. OLX72021 is an RNA-based treatment that is administered via intradermal injection into the balding scalp and suppresses the androgen receptor by reducing its gene expression. The trial was conducted with 30 males with androgenic alopecia who were split into 5 groups of six. The participants were injected with differing doses in six balding areas with follow-up over 8 weeks. No serious adverse events occurred, and there was no increase in adverse events with the dose.
Kintor Pharmaceuticals Continues Trials for KX-826 in Male Androgenic Alopecia Patients
Kintor Pharmaceuticals has enrolled its first subject in a Phase 2/3 trial of KX-826 1% (pyrilutamide) for treating male androgenic alopecia. The trial is a multi-centre, randomized, double-blind, vehicle-controlled phase 2/3 trial in which male AGA patients will apply the product topically. The phase 3 part of the trial will involve 25 research centers in China and will enroll 666 patients over 5 months. The trial will last 24 weeks, with a further month of safety observation.
Stemson Therapeutics Shuts Down
We reached out to Stemson Therapeutics for confirmation and have received the news that, yes, Stemson Therapeutics has shut down. Here is a quote from Geoff Hamilton, CEO. "I can confirm that we have shut down. It is a very disappointing outcome. I will say that pursuing a truly curative approach to hair loss with a true tissue regeneration therapy is still frontier science. While it offers the promise to be curative and durable, it is a significant challenge to develop such a solution involving living cellular medicines. It requires huge investment and dedication to the mission. There simply was no appetite or dedication in the biotech investment community during this historically bad biotech industry downturn to support Stemson with the major funding we needed to get the solution through the final stage of development and into the first clinical trial. We would love to see this technical approach picked back up in the future, as we firmly believe it will lead to a new breakthrough solution. But now was simply not our time to get the large investment needed."
Sun Pharma Delayed Release of Leqselvi for Alopecia Areata
Sun Pharma has had to delay the release of their JAK inhibitor deuruxolitinib (Leqselvi) thanks to an injunction from biopharma company Incyte. Incyte sells a JAK inhibitor called ruxolitinib, which is approved for non-hair loss-related indications like some blood cancers and graft-versus-host disease and as a topical for atopic dermatitis and vitiligo. Incyte claims that Leqselvi is structurally the same as ruxolitinib and, therefore, treads on their patent - which doesn't expire until 2026.
Sun Pharma will appeal the injunction; however, if they lose the appeal, they could be waiting until patent expiration before they can release their drug.