As of March 2023, 740 male patients have been enrolled in this study. This study is designed to evaluate the efficacy and safety profile of pyrilutamide for male pattern hair loss. The trial duration is 24 weeks with a 4-week follow-up. The primary endpoint is to see the change in non-vellus TAHC from baseline at the end of week 24. The results are expected by December 2023. How to use pyrilutamide? The blood concentration of pyrilutamide among the subjects remained extremely low throughout the study. In terms of safety, there were no associated severe adverse drug events. Phase-2 clinical trials Pyrilutamide (KX-826) is a topical androgen receptor (AR) antagonist, being developed as a potential topical treatment for androgenetic alopecia.

Pyrilutamide | Drug Developments | Pipeline Prospector Pyrilutamide | Drug Developments | Pipeline Prospector

Results showed that the pyrilutamide 0.5% solution applied once daily significantly increased the hair count by 11.39 hairs per cm 2 from baseline after 24 weeks of treatment. Improvement in hair density was seen as early by the end of week 12. Like the previous phase II trials, it exhibited a good safety profile. Additionally, Kintor’s hair loss drug is also being explored as a treatment for acne vulgaris. The use of pyrilutamide as a treatment for acne vulgaris is still in the preclinical stage in the United States, but it’s already started phase II clinical trials in China. How Does Pyrilutamide Work for Hair Loss? A recently completed phase-1 clinical trial done in the US was a randomized, double-blind, placebo-controlled, parallel-group, and dose-escalation study. It involved 40 healthy adult male patients with androgenetic alopecia. GlobalData provides a great range of information and reports on various sectors that is highly relevant, timely, easy to access and utilise. The reports and data dashboards help engagement with clients; they provide valuable industry and market insights that can enrich client conversations and can help in the shaping of value propositions. Moreover, using GlobalData products has helped increase my knowledge of the finance sector, the players within it, and the general threats and opportunities. I would be seriously interested to see if there's any chance whatsoever that when DHT bindings at the Androgen Receptor are cut, whether even people with "dead zones" usually considered past the 50% point of miniaturisation might show regrowth with this new or combined treatments.The most detailed pyrilutamide clinical trial results currently available come from press releases and a poster created for the Annual Meeting of the Chinese Hair Research Society sponsored by the Chinese Society of Dermatology. According to this poster presentation, 120 Chinese men with moderate pattern hair loss symptoms (Norwood-Hamilton classification IIIv, IV, or V) enrolled in this phase II clinical trial. Pyrilutamide is an androgen receptor antagonist that prevents dihydrotestosterone (DHT) from binding to its receptors in hair follicles. This prevents the effects of androgens on the hair follicle, such as miniaturization and eventual hair loss. GlobalData’s ML algorithm utilizes historical data to determine the probability of successful progression and market authorization for pipeline drugs from their current development stage. The historical data set is prepared to train the ML classifier. Once the algorithm is trained and recognizes a specific pattern, it is applied to the test data. The key learning are further tuned for hyperparameters to derive the optimum model. Based on the results of the previous clinical trial, future pyrilutamide clinical trials in men with androgenic alopecia will likely exclusively proceed with the application of 5 milligrams of pyrilutamide twice a day, while those for women will likely use 5 milligrams of pyrilutamide once a day. It is not yet known which dose is being used on the men and women participating in the long-term pyrilutamide safety study, or if these results will have any bearing on the dose tested for upcoming acne vulgaris pyrilutamide trials.

Likelihood of Approval and Phase Transition Success Rate

PR Newswire. (2023, 28 March) Kintor Pharma Announces Completion of Subject Enrollment in Phase III Clinical Trial of KX-826 for Treatment of Male Androgenetic Alopecia in China. Bloomberg.com. Kinter, K. J., & Anekar, A. A. (2022). Biochemistry, dihydrotestosterone. In StatPearls [Internet] . StatPearls Publishing. The ML model is further supplemented with an additional algorithm proprietary to GlobalData to predict PTSR and LoA. Each of the data attributes are assigned a weighted average score based on its direct impact on a drug’s clinical transition. The weighted average score represents a scale between a minimum to a maximum value based on the Raw Scores. The final score of an attribute is achieved by multiplying the Raw Score with the Weighted Score for each data attribute. All scores are added to determine the PTSR value.

It's a game changer imo because as somebody above mentioned, people that can't tolerate Finasteride/Dutasteride orally or topically because of sides no longer have to worry about that issue and still have the ability to save their hair. Yes, hair regrowth unfortunately is something that's eluding us with only cases where male to female transitions are taking place and that level of pharmacology seems to show anecdotally complete regrowth of hair. Obviously not something a majority of biological males wishing to remain so would ever consider but i do actually agree with you that combining this with Finasteride could show a strong synergistic element but only time will tell. KX-826 is an androgen receptor (AR) antagonist and a potential first-in-class topical drug for the treatment of AGA and acne vulgaris. For the AGA indication, in September 2021, Kintor Pharma announced the primary endpoint of the phase II clinical trial of KX-826 on male adults was met, with results demonstrating a positive efficacy and safety profile. Obtain information on LOA and PTSR for competitors’ drugs to plan your clinical development, commercialization and marketing strategies

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Results of Kintor’s Phase Ib Clinical Trials of Pyrilutamide in America, Kintor Pharmaceutical Limited (2022). Accessed online: https://en.kintor.com.cn/news/129.html That's why i was curious that if it was combined possibly with Finasteride for an experiment whether maybe it could be a more potent solution to the issue of Minoxodil. With topical or Oral Minoxodil we know that you have to indefinitely continue that treatment to maintain the hair it regrows even if you take Finasteride but i am curious whether people who regrow hair with the use of both Finasteride and Pyrilutamide could hypothetically maintain all the hair say by switching over to just one rather than losing ground like people usually do when they stop Minoxidil. A derma pen from experience feels different even at 1mm to say a derma roller and that's why it's sometimes best to start off with a depth that's not causing you too much discomfort. So for those of us currently suffering hair loss, the gold standard has been for many years the adapted dosages of "Accidental Hair Loss Treatments" like Finasteride/Dutasteride and Minoxodil in oral or topical forms.

What is Likelihood of Approval (LoA)?

Quoting from their press brief, The results are statistically and clinically meaningful and demonstrated a favorable safety profile. The company is preparing for subsequent FDA meetings on the results of the Phase-2 clinical trial and intends to commence Phase-3 clinical trials in the US/globally. Phase-3 clinical trials Several clinical trials have been done in China and in the US. In 2020, the first phase-2 clinical trial was a multi-regional randomized placebo-controlled study done in China.

Kintor reports positive data from trial of androgenetic

Kintor Pharmaceutical Limited has announced results of a phase II clinical trial of pyrilutamide (KX-826), a potential first-in-class topical drug, for the treatment of adult female androgeneticalopecia (AGA). The primary endpoint is the change from baseline in non- vellus target area hair count (TAHC) at the end of week 24. The drug will be dosed at 10 mg (0.5% BID) per patient per day in the trial. [4] Adverse effects [ edit ] A total of 160 female AGA patients who have met Savin Scale (D3-D6) were enrolled in the phase II clinical trial, with 119 patients randomly assigned to four treatment groups. Pivotal study

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Kintor Pharma Announces First Patient Dosing of Phase III Clinical Trial of KX-826 (Pyrilutamide) for Treating Androgenic Alopecia Patients in China, Kintor Pharmaceutical Limited (2022). Accessed online: https://en.kintor.com.cn/news/202.html Dominguez‐Santas M, Diaz‐Guimaraens B, Saceda‐Corralo D, Hermosa‐Gelbard A, Muñoz‐Moreno Arrones O, Pindado‐Ortega C, Fernandez‐Nieto D, Jimenez‐Cauhe J, Ortega‐Quijano D, Suarez‐Valle A, Jaen‐Olasolo P. (2022). The state‐of‐the‐art in the management of androgenetic alopecia: A review of new therapies and treatment algorithms. JEADV Clinical Practice. Jianzhong Zhang, chairman of the Department of Dermatology, Peking University People’s Hospital, is the leading principal investigator. The primary endpoint for the trial is the change from baseline versus placebo in TAHC at the end of week 24.