The trial for TDM-105795 has been completed, and it was in phase 2A. The discussion seeks input on the next phases, 2B or 3, based on safety and efficacy.
PP405's phase 2a trial results were presented, focusing on safety and pharmacokinetics, with a future meeting planned to share the full dataset. The trial includes a randomized controlled portion and an open-label extension, with no indication of phase 2B completion.
The conversation is about a user seeking information on a clinical trial by Amplifica - Scube3 for Androgenetic Alopecia (AGA). The user is unsure if it's a formal phase 1 study.
The FDA will now require only one clinical trial for drug approval, potentially speeding up the release of hair loss treatments like PP405. Pelage is expected to present full results of PP405 Phase 2a trials and move to Phase III in mid-2026.
The conversation discusses the delay in the PP405 Phase 2 study results, now expected by the end of 2025, and skepticism about research practices. There is also mention of optimism for Amplifica's AMP303 and a topical treatment in early testing.
The conversation discusses the safety study of PP405, emphasizing that early trials focus on safety rather than efficacy, and that any efficacy data from such a short study should be viewed skeptically. It also highlights that the information released is primarily for securing funding, and that meaningful efficacy results are expected in later phases.
The conversation is about a user considering joining a clinical study for Clascoterone (Breezula) after experiencing no results with topical finasteride and minoxidil, and side effects from oral finasteride. The user is seeking advice on clinical study participation and experiences.
PP405 shows initial promise for treating androgenetic alopecia, with safety confirmed in early trials, but skepticism remains due to limited data. Further trials are needed to determine its true efficacy and potential market impact.
A Phase 1 update for the HMI 115 clinical trial, which involves 16 participants and is expected to end in July 2023; as well as changes to the recruitment process, including treatment protocols with Minoxidil, Finasteride, and RU58841.
Amplifica is testing a compound called AMP-303 for hair loss, but it's not Scube3 or osteopontin. The timing for the results from the clinical trial is unknown.
Pelage is moving to Phase III clinical trials for PP405, a hair loss treatment, with results to be presented at a medical meeting. Users express skepticism and hope, comparing it to existing treatments like Minoxidil and finasteride, while discussing the potential for new hair growth in previously bald areas.
Cosmo Pharmaceuticals has enrolled about 850 out of 1400 patients for their phase 3 clinical trials of clascoterone (Breezula) and claims to be on schedule. The conversation is about hair loss treatments.
People are discussing the anticipated release of PP405 phase 2a results, expected by the end of March, with some skepticism about its effectiveness. There is cautious optimism due to past experiences with similar treatments like Breezula, despite concerns about the lack of presentation at the AAD 2026 conference.
The conversation discusses a clinical trial for Setipiprant in the US, starting June 29th, with eligibility excluding recent users of minoxidil or finasteride. It encourages informed decision-making before signing up.
The conversation discusses hair loss treatments, mentioning minoxidil, finasteride, RU58841, VDPHL, GT20029, and follicle cloning as potential solutions. It also reveals that the discussion about PP405 was an April Fool's joke.
Clascoterone in Winlevi, a topical AR antagonist, is being re-examined due to concerns about HPA axis suppression in adolescents, but it's unlikely to be banned for adult use in androgenetic alopecia (AGA). The European Medicines Agency recommended refusing Winlevi for acne vulgaris, but this may not affect Breezula's approval for AGA.
Clascoterone's European release is expected in Q4 2026, with FDA approval anticipated by mid-2027. The discussion includes questions about the approval timeline and potential acceleration due to unmet needs.
Pelage is delaying the start of phase 3 trials for PP405 to 2026 due to necessary regulatory processes, despite having $120 million in funding. Users discuss the potential of PP405 for hair regrowth, with some expressing skepticism and others hopeful for new treatments like Breezula.
12 companies having drugs or therapies in clinical trials during 2023, with various molecules and phases of trial; the probability that some may fail; and progress being made in the field.
A user is joining a clinical trial for Clascoterone, a drug approved for acne but being tested for hair loss. They previously tried finasteride with limited success and plan to share updates on their experience with the new treatment.
A user is advocating for Phase 3 trials of the hair loss treatment PP405 to be conducted in Germany, citing benefits like a diverse patient base and faster access for European patients. Despite skepticism about the petition's influence, the user believes it can demonstrate significant interest and potentially influence strategic decisions.
A phase 3 trial for Breezula (clascoterone solution) to treat male pattern hair loss has been listed, with 726 participants and a completion date of January 2025. Other treatments mentioned include Aneira Pharma's combination of minoxidil and latanoprost, Triple Hair's combination of minoxidil, latanoprost, and finasteride, and a new microneedling and LLLT device called StimuSIL.
The conversation discusses disappointment over only receiving a financial report from Cassiopea instead of trial results for Breezula/CB-03-01, a hair loss treatment. However, there is optimism as the company is advancing Breezula into Phase III trials for men, starting trials for women, and submitting an NDA for their acne product, Winlevi.
A Phase II clinical trial for TDM-105795 has started recruiting in the US, and it might be a promising treatment for hair loss. Many hair loss drugs, including this one, originate from China.
The conversation discusses the progress of Clascoterone (Breezula) for hair loss treatment, noting that COVID-19 delayed female trials by three months but Phase III trials for males are proceeding with a Special Protocol Assessment filed with the FDA. Users express hope for Breezula as an alternative to existing treatments like finasteride and minoxidil, despite concerns about its potential high cost.
PP405 is a topical gel being tested for hair regrowth in adults with androgenetic alopecia. Volunteers aged 18-55 are needed for a 16-week trial in several US locations.
Clascoterone solution is in Phase III trials for male androgenetic alopecia, with results expected in the second half of 2025. Commercialization is anticipated in about 2-3 years, but there are concerns about delays and market expectations.
PP405, a potential hair loss treatment, is facing delays in releasing Phase 2 results, causing frustration among users who compare it to past failed treatments. Despite skepticism, some remain hopeful about PP405's future, while others discuss alternative treatments like Clascoterone and its expected market release.
Pelage plans to conduct two Phase 3 trials for PP405, a new hair loss treatment, which may take about a year to complete. Users discuss various hair loss treatments, including pyrilutamide, minoxidil, finasteride, and clascoterone, with some expressing impatience over the lengthy trial process compared to faster drug approvals like the COVID vaccine.