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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 Does anyone know when GT20029 could be available in the grey market?

in Research/Science 10 upvotes 1 year ago

The conversation discusses the potential availability of a new hair loss treatment, GT20029, on the grey market, with users suggesting it could be within a year but advising against using grey market products due to safety concerns and complexity of the drug.

community Eucapil/fluridil - have you heard of it? What’s your opinion?

in Treatment 3 upvotes 3 months ago

Eucapil/fluridil is discussed as a potential treatment for hair loss, with questions about its effectiveness and why it isn't a primary treatment. Minoxidil, finasteride, and RU58841 are also mentioned as treatments.

community 12M post-op +dutasteride daily / FUE 3000Hairs in Korea

in Progress Pictures 517 upvotes 4 months ago

A user shared progress pictures 12 months after a hair transplant and daily use of dutasteride. The conversation discusses the quality of comparison photos and the use of hair fibers.

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 Just to show you the superiority of dutasteride over finasteride (it's huge)

in Research/Science 58 upvotes 5 months ago

Dutasteride is shown to be significantly more effective than finasteride for treating male androgenic alopecia. Users discuss the difficulty of obtaining dutasteride in some countries and share personal experiences with its effectiveness and side effects.

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 Lilly to seek first approval of an autoimmune drug for hair loss

in Research/Science 19 upvotes 3 years ago

Eli Lilly's drug baricitinib showed effectiveness in treating alopecia areata, with higher doses resulting in significant hair regrowth compared to placebo. The treatment is not for male pattern baldness.

community Winlevi just got FDA approval, projected to be available early 2021 in the US

in Treatment 45 upvotes 4 years ago

The conversation is about creating a higher concentration of the newly FDA-approved hair loss treatment, Clascoterone (Winlevi), through compounding pharmacies and possibly organizing group purchases. Some users are unfamiliar with Winlevi and are asking for an explanation of the drug.

community Anyone remember Breezula, the promising hairloss drug that was perpetually 3 years away? Well, it's available right now as an acme treatment. Can we just directly apply to the scalp?

in Treatment 39 upvotes 3 years ago

The conversation discusses the availability of Breezula, a drug for hair loss, now being sold as an acne treatment, and whether it can be applied to the scalp. Users express skepticism about new hair loss treatments and suggest waiting for FDA approval.

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 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 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 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 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 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 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.

community What would hair loss treatment be like in the 2030s?

in Treatment 5 upvotes 4 months ago

The conversation discusses future hair loss treatments, with mentions of dutasteride potentially gaining FDA approval and increased popularity. Skepticism remains about significant advancements due to limited funding and reliance on cosmetic companies.

community My Pyrilutamide Experience Update 2, Part 1

in Update 63 upvotes 1 year ago

The user's experience taking Pyrilutamide, a drug for hair loss treatment, and their use of it in combination with other treatments such as Minoxidil, Finasteride and RU58841. They have experienced positive results so far with no major side effects.

community Starting pyrilutamide boys wish me luck!

in Treatment 36 upvotes 2 years ago

A user beginning to take Pyrilutamide as a treatment for their hair loss, and other users sharing their experiences with the drug or similar treatments such as Minoxidil, Finasteride, and RU58841.

community Information regarding Kintor’s GT20029

in Product 40 upvotes 2 years ago

The conversation discusses skepticism about the effectiveness of new hair loss treatments, mentioning that despite 40 years of research, only accidental discoveries like Minoxidil and Finasteride have been made. It also notes that drug development is a slow process, often taking a decade or more to bring a new drug to market.