nomelcitinib (D-2570) / InventisBio - LARVOL DELTA

D2570-107: The Study is to Investigate D-2570 in Participants With Different Levels of Kidney Function. (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: InventisBio Co., Ltd

New P1 trial • Renal Disease

A Pharmacokinetic Study of D-2570 in Participants With Hepatic Impairment and Normal Hepatic Function (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: InventisBio Co., Ltd

New P1 trial • Hepatology

D2570-202: A Phase 2 Study of D-2570 in Subjects With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: InventisBio Co., Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

D2570-206: Study of D-2570 in Subjects With Non-Segmental Vitiligo (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: InventisBio Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Vitiligo

N/Z: A Study to Evaluate D-2570 in Participants With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=75 | Recruiting | Sponsor: InventisBio Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis

D2570-206: A Phase 2 Study of D-2570 in Subjects With Non-Segmental Vitiligo (clinicaltrials.gov) - P2 | N=160 | Not yet recruiting | Sponsor: InventisBio Co., Ltd

New P2 trial • Dermatology • Immunology • Vitiligo

Healthy Volunteer Study (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: InventisBio Co., Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed

Mass Balance Study of [14C] D-2570 (clinicaltrials.gov) - P1 | N=8 | Active, not recruiting | Sponsor: InventisBio Co., Ltd | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Apr 2026 ➔ Aug 2026

Enrollment closed • Trial completion date

A Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=477 | Recruiting | Sponsor: InventisBio Co., Ltd | Trial completion date: Aug 2027 ➔ Dec 2027 | Trial primary completion date: Apr 2027 ➔ Jul 2027 | Not yet recruiting ➔ Recruiting

Enrollment open • Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

A Study of D-2570 in Patients With Active Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: InventisBio Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

D2570-204: A Phase II Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) - P2 | N=222 | Recruiting | Sponsor: InventisBio Co., Ltd | Trial primary completion date: Mar 2027 ➔ Aug 2027

Trial primary completion date • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

N/Z: A Study to Evaluate D-2570 in Participants With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=75 | Not yet recruiting | Sponsor: InventisBio Co., Ltd

New P2 trial • Dermatology • Immunology • Psoriasis

Mass Balance Study of [14C] D-2570 (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: InventisBio Co., Ltd

New P1 trial

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Oral TYK2 Inhibitor D-2570 in Healthy Subjects: A First-in-Human Phase I Study. (PubMed, Clin Transl Sci) - "These results provide the rationale for dose selection in future clinical trials and support advancing D-2570 as a potential treatment option for autoimmune diseases mediated by tyrosine kinase 2. Trial Registration: Chinadrugtrials.org.cn (CTR20222168)."

Clinical • First-in-human • Journal • P1 data • PK/PD data • Immunology • IFNG • IL12A • IL18 • TYK2

A Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis. (clinicaltrials.gov) - P3 | N=477 | Not yet recruiting | Sponsor: InventisBio Co., Ltd

New P3 trial • Dermatology • Immunology • Psoriasis

A Study of D-2570 in Patients With Active Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: InventisBio Co., Ltd

New P2 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

D2570-204: A Phase II Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) - P2 | N=222 | Recruiting | Sponsor: InventisBio Co., Ltd

New P2 trial • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Evaluate the Efficacy and Safety of D-2570 in Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=390 | Recruiting | Sponsor: InventisBio Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis

Healthy Volunteer Study (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: InventisBio Co., Ltd

New P1 trial

Novel TYK2 inhibitor D-2570 in moderate to severe plaque psoriasis: a randomized, double-blind, placebo-controlled, phase 2 trial. (PubMed, J Am Acad Dermatol) - P2 | "D-2570 demonstrated a high efficacy with favorable safety profile in patients with moderate to severe plaque psoriasis."

Clinical • Journal • P2 data • Immunology • Psoriasis • IL17A • TYK2

Evaluate the Efficacy and Safety of D-2570 in Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=390 | Not yet recruiting | Sponsor: InventisBio Co., Ltd

New P3 trial • Dermatology • Immunology • Psoriasis

Yifang Biopharma D-2570 tablets start Phase III clinical trial for moderate to severe plaque psoriasis [Google translation] (Sina Corp) - "Data from the Drug Clinical Trial Registration and Information Disclosure Platform show that a multicenter randomized, double - blind , placebo - controlled Phase III clinical study evaluating the efficacy and safety of D-2570 in the treatment of moderate to severe plaque psoriasis has been launched by Yifang Biotechnology (Shanghai) Co., Ltd. The clinical trial registration number is CTR20252503, and the first public information date is July 2, 2025...The main purpose of this trial is to evaluate whether different doses of D-2570 are better than placebo in the treatment of moderate to severe plaque psoriasis patients at week 16; secondary objectives include evaluating long-term treatment effects, safety, and population pharmacokinetic and pharmacodynamic characteristics....Currently, the experiment is in progress (not yet recruited), with a target enrollment of 390 people."

Trial status • Psoriasis

D2570-202: A Phase 2 Study of D-2570 in Subjects With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: InventisBio Co., Ltd

New P2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Yifang Bio: D-2570 completed first patient dosing in Phase II clinical trial for ulcerative colitis [Google translation] (Eastmoney.com) - "Regarding the latest clinical progress of D-2570, the company stated that the Phase II clinical trial application for D-2570 for the indication of ulcerative colitis has been approved by the CDE, and the first patient in the trial was dosed in May 2025."

Trial status • Ulcerative Colitis

D2570-201: Evaluate the Efficacy and Safety of D-2570 in Participants With Moderate-to-Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=161 | Completed | Sponsor: InventisBio Co., Ltd | Recruiting ➔ Completed | Trial completion date: Mar 2025 ➔ Nov 2024

Trial completion • Trial completion date • Dermatology • Immunology • Psoriasis