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    GlossaryDrug Approval Process

    rigorous steps to get new drugs approved by authorities

    The Drug Approval Process is a rigorous series of steps that a pharmaceutical company must follow to get a new drug approved for public use by regulatory authorities, such as the FDA in the United States. This process includes preclinical research, multiple phases of clinical trials to test safety and efficacy, and a thorough review of all data before the drug can be marketed.

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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 No, Finasteride as a treatment for MPB was not an "accident"

      in Research/Science  105 upvotes 3 years ago
      Finasteride was intentionally developed to treat BPH and later approved for male pattern baldness (MPB) due to its 5AR inhibition effects. The delay in MPB approval was due to concerns about off-label use for female hirsutism and the prioritization of treating a more debilitating condition.

      community If RU58841 is such an effective anti androgen

      in Research/Science  47 upvotes 10 months ago
      RU58841 is discussed as a topical anti-androgen for hair loss, but its effectiveness and safety are not well-documented, leading to mixed opinions and experiences among users. Some combine it with finasteride, but concerns about side effects and lack of FDA approval limit its popularity.

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

      in Chat  31 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 FINASTRIDE and switch to DUTASTRIDE, my experience

      in Progress Pictures  134 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 Likelihood of new treatments in the next few years?

       10 upvotes 9 years ago
      New hair loss treatments like Shiseido/Replicel and Histogen were discussed, with cautious optimism about their availability by 2018. Setipiprant, Replicel, and Bimatoprost were mentioned as potential treatments expected around 2016-2017.

      community Dutasteride is for Young Hair Loss Suffers

      in Finasteride/Dutasteride  104 upvotes 2 months ago
      Dutasteride is discussed as a treatment for young hair loss sufferers, with mixed experiences regarding side effects and effectiveness. Some users report positive results with Dutasteride, while others prefer Finasteride or Minoxidil due to fewer side effects.

      community Kintor Pharmaceutical Announces AR-PROTAC (GT20029) Approved for Acne and Androgenic Alopecia Clinical Trials in China

      in Technology  15 upvotes 3 years ago
      The conversation discusses the approval of Kintor Pharmaceutical's AR-PROTAC (GT20029) for clinical trials in China for acne and androgenic alopecia. One user expresses optimism about new treatments being developed and seeks clarification on how the new drug works, specifically if it temporarily degrades the AR protein to reduce DHT sensitivity in hair follicles.

      community My experience with Pyrilutamide

      in Update  3 upvotes 8 months ago
      The user experienced a slight decrease in hair shedding and scalp itch, and reduced sebum production using Pyrilutamide, but stopped due to chest pain, breathing difficulties, and heart issues. They felt normal a week after discontinuing and doubted FDA approval for the drug.

      community Silicon Valley backed company aims to cure hair loss

      in Technology  51 upvotes 2 years ago
      A Silicon Valley-backed company aims to cure hair loss. Exciting advancements include mRNA therapies, gene editing, hair cloning, AR degraders, anti-androgens, cell-based rejuvenation, and AI-based drug discovery, with hopes for FDA approval of GT20029 within 10 years.

      community Kintor develop GT20026 Anti-Androgen receptor drug with NO SIDES

      in Treatment  16 upvotes 3 years ago
      The conversation discusses GT20029, a new topical drug for hair loss and acne without notable side effects, which has been accepted for investigational use in China. Some users express skepticism about the legitimacy of the company and the potential for other drugs like RU58841 to be developed due to patent expiration and lack of profitability.

      community Don’t get too hyped up about Breezula, it‘s not a wonder drug

       22 upvotes 5 years ago
      The conversation discusses skepticism about Breezula, a hair loss treatment, with the consensus that it's not a miracle cure but a maintenance drug that may work well with finasteride. Some users report side effects from finasteride, like sexual dysfunction, while hoping for better results from Breezula or RU58841 without such side effects.

      community Clascoterone (Winlevi) now approved in Canada

      in Product  14 upvotes 1 year ago
      The conversation is about the approval of Clascoterone (Winlevi) in Canada for hair loss treatment. One user expressed skepticism about its effectiveness due to low concentration.

      community Earliest we can get legitimate pyrilutamide

      in Research/Science  47 upvotes 2 years ago
      Pyrilutamide, a drug in phase 3 trials in China, potentially becoming available in late 2023 or early 2024; Finasteride being used as a current treatment for hair loss; and the possibility of joining a group buy for black market versions of Pyrilutamide.

      community FDA approves Cassiopea's WINLEVI (CB-03-01, 1% formulation) for Acne

      in Technology  34 upvotes 4 years ago
      The conversation is about the FDA approval of WINLEVI for acne treatment and the anticipation of Breezula, a hair loss treatment using the same active ingredient, which may indicate a positive future for Breezula's release. There is disappointment that Breezula's results are not optimal, but it is seen as progress in hair loss treatment.

      community HMI-115 question about potential earliest access

      in Research/Science  9 upvotes 1 year ago
      Hair loss treatments discussed include Minoxidil, Finasteride, and RU58841. HMI-115, a monoclonal antibody drug, is in phase 1 and 2 trials for different conditions, but its availability on the gray market is unlikely due to high production costs.

      community Kintor Phase 2 Results released KX-826 (pyrilutamide)

      in Research/Science  454 upvotes 2 years ago
      Kintor Pharmaceutical's Phase 2 results with the drug Pyrilutamide, a potential alternative to 5-ARI drugs like Finasteride and Dutasteride but without the side effects. It could be used in combination with other topical treatments such as Minoxidil. The safety of the drug has been demonstrated in 6 months of use, however there are still questions about long term efficacy and systemic absorption.

      community Binding affinity of pyrilutamide!

      in Update  169 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 Clascoterone (Winlevi) Update for Canada

      in Treatment  16 upvotes 2 years ago
      Clascoterone cream was submitted for review to Health Canada in August 2022, with hopes of approval within 3-6 months. It may potentially enhance finasteride's effects for hair loss treatment.

      community Fevipiprant 2019!

       17 upvotes 8 years ago
      The conversation discusses Fevipiprant, an asthma drug that may block CRTH2 and potentially stop male pattern baldness (MPB) without inhibiting DHT. It also mentions the use of finasteride and dutasteride for hair loss.