SYHX1901 / CSPC Pharma - LARVOL DELTA

New drug SYHX1901 tablets begins clinical trials! Is there hope for psoriasis patients? [Google translation] (Sohu.com) - "Recently, CSPC Pharmaceutical Group Ouyi Pharmaceutical Co., Ltd. announced that its new drug, SYHX1901 tablets, has initiated Phase I clinical trials, bringing new hope to psoriasis patients...The primary objectives of this clinical trial are to evaluate the safety, tolerability, and pharmacokinetic profile of SYHX1901 tablets in healthy volunteers. The trial will last for seven days, with participants taking the drug orally once daily after meals. The doses are 30mg and 60mg. This phase of the study will also focus on the drug's effects on the QT interval to ensure its safety in cardiac health."

Trial status • Psoriasis

Study to Evaluate Safety and Efficacy of SYHX1901 Tablets in Severe Alopecia Areata Patients (clinicaltrials.gov) - P2 | N=156 | Not yet recruiting | Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. | Trial completion date: Dec 2026 ➔ Nov 2027 | Initiation date: Nov 2024 ➔ May 2025 | Trial primary completion date: Dec 2025 ➔ May 2027

Trial completion date • Trial initiation date • Trial primary completion date • Alopecia • Dermatology • Immunology

A Phase III Study of SYHX1901 Tablets in the Treatment of Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=500 | Not yet recruiting | Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.

New P3 trial • Dermatology • Immunology • Psoriasis

Efficacy and safety of SYHX1901 in moderate-to-severe plaque psoriasis: a multicenter, randomized, double-blinded, placebo-controlled, phase 2 trial (EADV 2024) - P2 | "Data from this phase II study indicate that SYHX1901 is well tolerated and efficacious in the treatment of moderate-to-severe plaque psoriasis. Further studies with large sample and long-term treatment are warranted to validate the findings. ClinicalTrials.gov Identifier: NCT05858047"

Clinical • P2 data • Cardiovascular • Dermatology • Dyslipidemia • Herpes Zoster • Immunology • Infectious Disease • Inflammation • Psoriasis • Respiratory Diseases • Tuberculosis • Varicella Zoster • TYK2

A Phase II Study of SYHX1901 Tablets in the Treatment of Severe Alopecia Areata (clinicaltrials.gov) - P2 | N=156 | Not yet recruiting | Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.

New P2 trial • Alopecia • Dermatology • Immunology

A Study to Evaluate the Efficacy and Safety of SYHX1901 Tablet in Non-segmental Vitiligo Patients (clinicaltrials.gov) - P2 | N=144 | Recruiting | Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.

New P2 trial • Dermatology • Immunology • Vitiligo

An Investigational Study to Evaluate Experimental Medication SYHX1901 Tablets With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=93 | Completed | Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

An Investigational Study to Evaluate Experimental Medication SYHX1901 Tablets With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=92 | Recruiting | Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.

New P2 trial • Dermatology • Immunology • Psoriasis

CSPC (01093.HK) "SYHX1901 Tablets" Approved for Clinical Trials for the Treatment of Severe New Coronary Pneumonia [Google translation] (Sina Corp) - "CSPC...announced that the 'SYHX1901 tablet' developed by the group has been approved by the State Drug Administration of the People's Republic of China, and can be used in China for the treatment of severe new coronavirus pneumonia ( COVID-19) clinical trials in adult patients."

New trial • Immunology • Infectious Disease • Novel Coronavirus Disease

CSPC onslaught of innovative drugs this year, 13 category 1 new drugs were approved for clinical trials [Google translation] (PharmNet.com) - "Since 2021, CSPC has received clinical approval for 13 new class 1 drugs, including small molecule chemical drugs...SYHX1901 tablets..."

New trial • Immunology • Rheumatoid Arthritis • Systemic Lupus Erythematosus

The Safety, Tolerability, and Pharmacokinetics of SYHX1901 Tablets in Chinese Healthy Subjects (clinicaltrials.gov) - P1; N=102; Recruiting; Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open