pyrilutamide (KX0826) / Kintor Pharma - LARVOL DELTA

First Subject Enrollment In Phase 3 Stage Of KX-826 1.0% For AGA (Kintor Pharma Press Release) - "Kintor Pharmaceutical Limited,,,announced that the Company has successfully completed the first subject enrollment recently in the phase III stage (the 'Phase III Stage') pivotal clinical trial of its in-house developed and potential first-in-class KX-826 tincture 1.0% for the treatment of male adult AGA in China. The Pivotal Clinical Trial is a multi-center, randomized, double-blind, vehicle controlled phase II/III study with adaptive designs to evaluate the efficacy and safety of KX-826 tincture 1.0% for the topical treatment of male adults with AGA in China....The Phase III Stage is expected to involve 25 clinical research centers in China and enroll 666 patients within 5 months....The Phase III Stage is expected to be completed by the end of 2025."

Trial status • Alopecia • Dermatology

Phase 2/3 Study of KX-826 Solution in Chinese Male Patients With Androgenetic Alopecia (clinicaltrials.gov) - P2/3 | N=756 | Not yet recruiting | Sponsor: Suzhou Kintor Pharmaceutical Inc,

New P2/3 trial • Alopecia • Dermatology • Immunology

To Evaluate Safety and Efficacy of KX-826 in Chinese Female Subjects With Androgenetic Alopecia (clinicaltrials.gov) - P2 | N=160 | Completed | Sponsor: Suzhou Koshine Biomedica, Inc.

New P2 trial • Alopecia • Dermatology • Immunology

Phase III Study of KX-826 With Adult Male Patients With AGA (clinicaltrials.gov) - P3 | N=740 | Active, not recruiting | Sponsor: Suzhou Kintor Pharmaceutical Inc, | Trial primary completion date: Jan 2024 ➔ May 2024

Trial primary completion date • Alopecia • Dermatology • Immunology

To Evaluate Efficacy, Safety, and Tolerability of KX-826 in Male Subjects With Androgenetic Alopecia (clinicaltrials.gov) - P2 | N=123 | Completed | Sponsor: Suzhou Kintor Pharmaceutical Inc, | Active, not recruiting ➔ Completed

Trial completion • Alopecia • Immunology

Phase III Study of KX-826 With Adult Male Patients With AGA (clinicaltrials.gov) - P3 | N=740 | Active, not recruiting | Sponsor: Suzhou Kintor Pharmaceutical Inc,

New P3 trial • Alopecia • Immunology

Efficacy and Safety of Different Doses of Topical KX-826 on Female Pattern Hair Loss: A Multicenter, Placebo-controlled, Double-blinded, Randomized Phase II Study (EADV 2023) - "KX-826 (Pyrilutamide) is a novel investigational androgen receptor (AR) antagonist, developed to locally block the androgen-mediated signal by competing with the biding of the androgen to AR instead of reducing androgen level systemically. With different mechanism to minoxidil, spironolactone or finasteride, topical AR antagonist KX-826 does not decrease production of hormones, current 0.5% QD regimen of KX-826 on FPHL showed promising results and was well tolerated, deserves further evaluation. Figure 1: Study Subject CONSORT Page 2** of 2**"

Clinical • P2 data • Alopecia • Contact Dermatitis • Dermatitis • Immunology • Infectious Disease • Pruritus • AR

Efficacy and Safety of topical KX-826 in Adult Male Subjects with Androgenetic Alopecia in China: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study (EADV 2023) - "For male subjects with AGA (Norwood-Hamilton classification type IIIv, Ⅳ, V), KX-826 was well tolerated and 0.5% BID group was significantly increased in TAHC at week 24 in comparison with that of the placebo group. Sensitivity analysis of the primary efficacy endpoint was consistent. The results will be further confirmed in a registration Phase III study."

Clinical • P2 data • Alopecia • Contact Dermatitis • Dermatitis • Dyslipidemia • Hypertriglyceridemia • Immunology • Pruritus • AR

Efficacy and Safety of topical KX-826 in Adult Male Subjects with Androgenetic Alopecia in China: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study (EADV 2023) - "For male subjects with AGA (Norwood-Hamilton classification type IIIv, Ⅳ, V), KX-826 was well tolerated and 0.5% BID group was significantly increased in TAHC at week 24 in comparison with that of the placebo group. Sensitivity analysis of the primary efficacy endpoint was consistent. The results will be further confirmed in a registration Phase III study."

Clinical • P2 data • Alopecia • Contact Dermatitis • Dermatitis • Dermatology • Dyslipidemia • Hypertriglyceridemia • Immunology • Pruritus • AR

Efficacy and Safety of Different Doses of Topical KX-826 on Female Pattern Hair Loss: A Multiple-centers, Placebo-controlled, Double-blinded, Randomized Phase II Study (EADV 2023) - "KX-826 (Pyrilutamide) is a novel investigational androgen receptor (AR) antagonist, developed to locally block the androgen-mediated signal by competing with the biding of the androgen to AR instead of reducing androgen level systemically. With different mechanism to minoxidil, spironolactone or finasteride, topical AR antagonist KX-826 does not decrease production of hormones, current 0.5% QD regimen of KX-826 on FPHL showed promising results and was well tolerated, deserves further evaluation. Page 2** of 2**"

Clinical • P2 data • Alopecia • Contact Dermatitis • Dermatitis • Immunology • Infectious Disease • Pruritus • AR

Phase II Study Evaluating the Efficacy and Safety of KX-826 (clinicaltrials.gov) - P2 | N=120 | Completed | Sponsor: Suzhou Kintor Pharmaceutical Inc,

New P2 trial • Alopecia

What's New in Therapy for Male Androgenetic Alopecia? (PubMed, Am J Clin Dermatol) - "Mesotherapy with dutasteride has also become more widespread recently, although evidence of its effectiveness is limited to retrospective studies in real clinical practice. The use of oral minoxidil in androgenetic alopecia has not been approved by the FDA, however several clinical studies have shown that it is an effective treatment option...Pyrilutamide and GT20029 are being studied as topical antagonists of the androgen receptor, while cetirizine is another topical option with some initial promising results. Furthermore, according to isolated studies with heterogeneous treatment schemes, the use of botulinum toxin in the scalp might improve androgenetic alopecia, and lastly, scalp threading might increase the total hair count as growth factors are released during implantation."

Journal • Alopecia • Dermatology • AR

Efficacy and Safety of topical KX-826 in Male Subjects with Androgenetic Alopecia:A Multicenter,Randomized,Double-blind,Placebo-controlled Phase II Study (ESDR 2022) - "Sensitivity analysis of the primary efficacy endpoint were consistent. The results will be further confirmed in a registration Phase III study."

Clinical • P2 data • Alopecia • Contact Dermatitis • Dermatitis • Immunology • Pruritus

To Evaluate Efficacy, Safety, and Tolerability of KX-826 in Male Subjects With Androgenetic Alopecia (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: Suzhou Kintor Pharmaceutical Inc, | Recruiting ➔ Active, not recruiting

Enrollment closed • Alopecia

To Evaluate Efficacy, Safety, and Tolerability of KX-826 in Male Subjects With Androgenetic Alopecia (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Suzhou Kintor Pharmaceutical Inc, | Not yet recruiting ➔ Recruiting

Enrollment open • Alopecia

To Evaluate Efficacy, Safety, and Tolerability of KX-826 in Male Subjects With Androgenetic Alopecia (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Suzhou Kintor Pharmaceutical Inc,

New P2 trial • Alopecia

"Kintor Pharma Reports First Patient Dosing in P-III Study of KX-826 (pyrilutamide) for Androgenic Alopecia in China @Pharmashot https://t.co/gnF4k1IsyS" (@Pharmashot)

Clinical • Alopecia

the Safety, Tolerability and PK of KX-826 in Healthy Males With Alopecia Following Topical Multiple Dose Ascending (clinicaltrials.gov) - P1; N=40; Completed; Sponsor: Suzhou Kintor Pharmaceutical Inc,; Active, not recruiting ➔ Completed

Trial completion • Alopecia

Safety, Tolerability and Pharmacokinetics of KX826 in Healthy Male Subjects With Androgenetic Alopecia Following Topical Single Ascending Dose Administration (clinicaltrials.gov) - P1; N=40; Completed; Sponsor: Suzhou Kintor Pharmaceutical Inc,

New P1 trial • Alopecia