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GlossaryRegulatory Approval

official authorization from agencies to market a product

Regulatory approval is the official authorization granted by governmental or regulatory agencies, such as the FDA in the United States, allowing a product, such as a new medication or medical device, to be marketed and sold. This process involves rigorous evaluation of the product's safety, efficacy, and quality through clinical trials and other scientific assessments to ensure it meets the required standards for public use.

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community A warning to anyone considering 3rd party sourcing PP405 or its analogs

in Treatment 26 upvotes 1 week ago

Be cautious when sourcing PP405 or its analogs from third-party suppliers due to potential safety risks and lack of regulatory approval. The conversation highlights concerns about counterfeit products and the absence of reliable testing, making it risky to use such treatments.

community Why is dutasteride approved for hair loss in Japan and South Korea but not for USA?

in Research/Science 34 upvotes 3 years ago

The reasoning for GSK's approval of dutasteride for hair loss in Japan and South Korea but not the US, with alternatives such as finasteride, minoxidil and RU58841 mentioned.

community Why doesn't phase 3 of PP405 start straight away?

in Chat 14 upvotes 3 months ago

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.

community Breezula 6 Month Topline Phase III Results Released

in Research/Science 173 upvotes 4 months ago

Breezula shows promising hair growth results, with up to 539% increase in hair count compared to placebo, and regulatory submissions are planned in the US and EU. Users are cautiously optimistic, noting the potential for Breezula to replace finasteride by targeting DHT without systemic effects.

community Good News, PP405 is out on Shopee

in Product 272 upvotes 1 month ago

A product called "PP405 Hair Follicle Serum" is being sold on Shopee, claiming to cure baldness without clinical trials or FDA approval, but users are skeptical and refer to it as "snake oil." Some users discuss testing the product's contents, while others share their experiences with hair loss treatments like finasteride.

community Every Single RU58841 Study Analysed - Youtube Video

in Research/Science 11 upvotes 1 year ago

RU58841 is discussed as a potential hair loss treatment, with comparisons to finasteride. There is interest in leaked trial data, but no official clinical validation or approval for RU58841.

community Pelage are going to do two phase 3 trials for PP405. How long will it take to complete two phase 3 trials?

in Chat 45 upvotes 3 months ago

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.

community Approve PP405 quickly you coward

in Satire 193 upvotes 9 months ago

Pelage Pharmaceuticals is developing PP405, a topical treatment for hair growth, currently in Phase 2a trials. There is skepticism about the company's claims, and no fast-tracking approval timeline has been detailed.

community Coegin Pharma to release Follicopeptide (FOL005) by Q2 2025

in Treatment 120 upvotes 1 year ago

Follicopeptide (FOL005) by Coegin Pharma will launch as a cosmetic hair growth treatment by Q2 2025, showing similar efficacy to finasteride. Users discuss the benefits and skepticism of releasing hair loss treatments as cosmetics rather than drugs.

community Topical finasteride now the safest possible path?

in Finasteride/Dutasteride 84 upvotes 1 year ago

Topical finasteride is considered a safer option for hair regrowth with fewer systemic side effects compared to oral finasteride. Some users report similar efficacy and side effects between topical and oral treatments, while others prefer topical due to reduced systemic exposure.

community Kintor starts a new Phase 3 for Pyri... (1+ year)

in Research/Science 16 upvotes 2 years ago

The conversation discusses Kintor's initiation of a new Phase 3 trial to assess the long-term safety of Pyrilutamide (KX-826) for hair loss, which will last 52 weeks. Specific treatments mentioned include Pyrilutamide.

community Why don't the Nizoral manufacturers promote their product for MPB?

in Ketoconazole 11 upvotes 3 years ago

Ketoconazole is somewhat effective for male pattern baldness (MPB), but the manufacturer promotes it for dandruff instead, possibly because the dandruff market is larger and to avoid confusion among dandruff sufferers without hair loss.

community End of Hair loss ( AGA ) ? Since they produce it in china probably we don’t need to wait other 10 yrs😁

in Treatment 268 upvotes 4 weeks ago

GT20029 is a new hair loss treatment in Phase 3 trials in China, using PROTAC technology to target androgen receptors, potentially with fewer side effects than finasteride and minoxidil. VDPHL01, a second-generation minoxidil, is also mentioned as potentially more effective.

community Clascoterone - what we have right now

in Research/Science 19 upvotes 1 month ago

Clascoterone is a topical treatment for androgenetic alopecia, showing modest to moderate hair regrowth, and may be available by 2027-2028. It is considered safer than finasteride, with discussions on its effectiveness compared to RU58841 and pyrilutamide.

community Update July 2025] Most Promising Hair Loss Treatments in Clinical Trials

in Research/Science 271 upvotes 9 months ago

Promising hair loss treatments in clinical trials include Pyrilutamide, GT20029, CB-03-01, and PP405, with potential market releases between 2027 and 2029. Hair cloning remains experimental and expensive, while existing treatments like finasteride, minoxidil, and microneedling continue to be used.

community Epibiotech will now offer off-the-shelf allogeneic hair multiplication treatment in South Korea

in Research/Science 80 upvotes 3 years ago

Epibiotech will offer off-the-shelf allogeneic hair multiplication treatment in South Korea, using dermal papilla cells from donors to grow hair in balding areas. This method is cheaper and less invasive than traditional hair transplants.

community Target Area Hair Count (TAHC) increase comparasion of all future treatments in clinical trial phases

in Research/Science 35 upvotes 1 year ago

Finasteride, Minoxidil, Bioneer CosmeRNA, Technoderma, Kintor, Hope, Breezula, and Follicum treatments showed increases in hair count, with Technoderma showing the highest increase at 24.3 hairs/cm². Amplifica has not yet published results.

community What’s your views on clascoterone 5% topical solution by cosmo

in Research/Science 23 upvotes 4 months ago

Clascoterone 5% topical solution shows promise for treating male-pattern hair loss by blocking DHT at the follicle without systemic absorption, potentially offering fewer side effects than oral treatments like finasteride. While results are promising, long-term safety and effectiveness need further study, and it may serve as a starting point for developing more effective treatments.

community Petition Alert: Let's Get PP405 Phase 3 Trials in Germany by 2026!

in Research/Science 57 upvotes 9 months ago

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.

community Baldness Breakthrough: microRNA Stimulates Hair Growth in Aging Follicles

in Technology 314 upvotes 2 years ago

miR-205, a tiny RNA, can stimulate hair growth by softening aging hair follicle stem cells in mice. Future tests aim to see if this can work in humans.

community Hope Medicine announces HMI-115 phase II clinical trial for androgenetic alopecia in China

in Research/Science 60 upvotes 3 years ago

Hope Medicine's announcement of the HMI-115 Phase II clinical trial for androgenetic alopecia in China; other related trials have been conducted or are ongoing in different countries, including Australia, US, and Europe. There is speculation that the product may be accepted across borders without additional testing.

community New and Interesting HairLoss Studies/Papers/Reviews

in Treatment 41 upvotes 6 years ago

Hair loss treatments discussed include Dutasteride with Ketoconazole, tissue engineering strategies, and androgenetic alopecia therapies. Massage doubles follicular retention, improving treatment effectiveness.

community So basically we will know the efficacy of HMI-115 in 3 months after the phase II study concludes in China?

in Chat 9 upvotes 3 years ago

Hair loss discussion mentions HMI-115 efficacy in 3 months after Phase II study. Users discuss treatment effectiveness and mention massive regrowth in previously bald areas.

community HMI 115 Phase 1 update: Changes to clinicaltrials.gov page

in Research/Science 24 upvotes 3 years ago

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.

community Binding affinity of pyrilutamide!

in Update 170 upvotes 3 years ago

Pyrilutamide, a nonsteroidal antiandrogen drug under development for the potential treatment of androgenic alopecia. The conversation discusses its binding affinity to the androgen receptor and the timeline for possible availability after trials are completed in the United States and China.

community Story time! The Great Unbalding (PP405)

in Research/Science 231 upvotes 5 months ago

PP405 is a promising new hair loss treatment that may reactivate dormant hair follicles without side effects. It could surpass traditional treatments like minoxidil and finasteride if successful in further trials.

community Petition: Make PP405 available tomorrow instead of 2030

in Satire 333 upvotes 9 months ago

PP405, a promising hair loss treatment, is expected to be available by 2027, with faster trials due to its topical nature. Users are eager for its release, comparing it to existing treatments like minoxidil and finasteride, but remain cautious about its long-term effectiveness.

community I hope ET-02 or PP405 will be released in the next 4-5 years

in Product 15 upvotes 10 months ago

PP405 is a potential hair loss treatment that may work by blocking signals that cause hair cells to stop growing, requiring daily application for effectiveness. It could serve as an alternative to minoxidil and finasteride, but it is not yet available on the market and may take several years to be released.

community The story of RU58841/ PSK3841

in Research 622 upvotes 1 year ago

RU58841, a potential hair loss treatment, was not commercialized due to marketability issues and lack of long-term safety data. Concerns about its formulation and delivery methods further complicate its use.

community Wtf have we been doing for the last 30 years

in Treatment 548 upvotes 1 year ago

Hair loss treatments like finasteride, minoxidil, and dutasteride work but have side effects. A permanent cure is still not available due to the complexity of hair loss and limited investment.