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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 Coegin Pharma to release Follicopeptide (FOL005) by Q2 2025

in Treatment 117 upvotes 2 months 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 Epibiotech will now offer off-the-shelf allogeneic hair multiplication treatment in South Korea

in Research/Science 78 upvotes 2 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 The story of RU58841/ PSK3841

in Research 622 upvotes 3 months 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 Amplifica’s AMP-303 Study Unveils New Hope for Hair Loss Treatments

in Treatment 39 upvotes 1 month ago

AMP-303, a new injectable treatment for androgenetic alopecia, showed promising results in increasing hair count and density with minimal side effects. The treatment demonstrated significant hair regrowth and durability, offering new hope for those with hair loss.

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

in Research/Science 38 upvotes 7 months 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 Kintor’s KX-826 Pyrilutamide!!

in Research/Science 149 upvotes 3 years ago

KX-826 hair loss treatment completed trials with mild side effects. GT20029 may be ultimate cure, destroying androgen receptors causing baldness.

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

in Research/Science 34 upvotes 2 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 Hope Medicine announces HMI-115 phase II clinical trial for androgenetic alopecia in China

in Research/Science 61 upvotes 1 year 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 44 upvotes 4 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 we’re just ok with taking a research chemical now?

in Treatment 181 upvotes 3 years ago

The conversation discusses the use of RU58841, a non-FDA approved research chemical for hair loss, with mixed opinions on its safety and effectiveness. Some users are willing to try it as a last resort after other treatments like Minoxidil and Finasteride failed, while others express concerns about potential long-term side effects and lack of official research.

community FINASTRIDE and switch to DUTASTRIDE, my experience

in Progress Pictures 135 upvotes 2 months ago

The user shared their experience with Finasteride and Dutasteride for hair loss. They initially had success with Finasteride but switched to Dutasteride after experiencing shedding, which continued, and are now considering a hair transplant.

community 15 months total on Dut/Min/RU and microneedling 1mm every other week

in Progress Pictures 1746 upvotes 2 months ago

The user reported significant hair improvement over 15 months using dutasteride, minoxidil (oral and topical), RU58841, ketoconazole, and microneedling. They are considering a hair transplant in 4-6 months.

community Currently crushing 3 (5mg) tablets of fin into my topical min. Anyone do the same? If so how much do you add.

in Treatment 186 upvotes 6 months ago

The conversation discusses using crushed finasteride tablets mixed with topical minoxidil for hair loss treatment. Users share their experiences and opinions on the effectiveness and proper concentration of this method.

community Only Minoxidil 2 Months Before After Photos

in Progress Pictures 132 upvotes 7 months ago

A user shared their 2-month hair growth progress using only Minoxidil, noting significant improvement and plans to continue despite a genetic predisposition to baldness. They apply Minoxidil twice daily, experienced a heat rash, and chose not to use Finasteride due to side effects.

community Recent Study finds Laser caps are more effective than 5% minoxidil for AGA

in Research/Science 124 upvotes 8 months ago

Laser caps are found to be more effective than 5% minoxidil for treating hair loss, and when combined with minoxidil, they are even more effective. Some users report positive results with laser treatments, while others see no change; the devices are FDA approved, but opinions on their efficacy vary.

community Protac degradation of the androgen receptor in mice shows good efficacy and no systemic drug could be found

in Research/Science 47 upvotes 1 year ago

The efficacy of degrading the androgen receptor through dermal application in DP cells, a delivery system for topical drugs that involves dissolving microneedles, and rosemary oil as an alternative anti-androgen.

community Pyrilutamide Phase 3 on its way

in Treatment 127 upvotes 2 years ago

Pyrilutamide Phase 3 approved, starting early 2022 with 416 subjects for 24 weeks. Drug potentially better than RU and Breezula, with some users reporting no side effects.

community why hair restoration has not been progressed for last 20 years?

in Chat 34 upvotes 1 year ago

The conversation discusses the lack of significant advancements in hair loss treatments beyond finasteride and minoxidil, questioning if hair restoration technology has reached a dead end. Hair transplant technology has improved, but new medications face challenges with market entry, cost, accessibility, and long-term effectiveness.

community Topical finasteride now the safest possible path?

in Finasteride/Dutasteride 72 upvotes 4 months 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 1 year 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 2 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 So basically we will know the efficacy of HMI-115 in 3 months after the phase II study concludes in China?

in Chat 10 upvotes 1 year 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 25 upvotes 1 year 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 168 upvotes 2 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 Transient and Permanent Effects of Finasteride Use

in Research/Science 154 upvotes 3 years ago

Potential side effects of 5AR inhibitors like finasteride and dutasteride. Users debate risks, benefits, and personal experiences with these hair loss treatments.

community Will kintor show pyrilutamide phase 3 trials result this q

in Treatment 2 upvotes 1 year ago

The conversation is about the release of a new phase 3 clinical trial for a year and questioning if the results of the 6-month clinical trials will be shown this quarter. The specific treatment discussed is Pyrilutamide.

community ‘Long term use of fin/dut may be associated with health risks including fatty liver disease, insulin resistance, type 2 diabetes, dry eye disease and potential kidney disease.’

in Research/Science 22 upvotes 4 months ago

Long-term use of finasteride and dutasteride may be linked to health risks like fatty liver disease, insulin resistance, type 2 diabetes, dry eye disease, and potential kidney disease. Some users believe the risks are low and the medications are generally safe.

community New Research- Creatine Increasing Scalp DHT Without Corresponding Serum DHT Increase

in Research/Science 122 upvotes 6 months ago

Creatine may increase scalp DHT without affecting serum DHT, potentially speeding up male pattern baldness (MPB) for those genetically prone. Treatments mentioned include Minoxidil, finasteride, and RU58841.

community Currently participating in the Extended Phase III clinical trial of Pyrilutamid in China

in Technology 81 upvotes 1 year ago

A user from China is participating in a clinical trial for Pyrilutamid, a potential hair loss treatment originally developed for prostate cancer. They've experienced no side effects except initial scalp itchiness, and will share results after the year-long trial.

community 7 months oral fin 1 mg once daily, 3 months min 5% once daily same length, same angle, same lighting

in Progress Pictures 306 upvotes 1 year ago

The post and conversation are about a user's progress in treating hair loss using oral finasteride and topical minoxidil. The user expresses regret for not starting treatment earlier.