AC-101 / Accro Biosci - LARVOL DELTA

On September 14, 2026...Accro Bioscience announced that AC-101 tablets have been included in the Rare Diseases Innovative Drug Development Encouragement Pilot Program (the 'Caring Plan-Extension')...of the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA), with Blau syndrome as the proposed indication (PRNewswire)

Non-US regulatory • Immunology • Inflammation

Accro Bioscience…announced that it will present efficacy and safety results from a Phase 1b proof-of-concept study evaluating AC-101, an oral selective RIPK2 inhibitor, as induction therapy in patients with moderate-to-severe ulcerative colitis, at UEG Week 2026 in Barcelona, Spain (October 17-20) (PRNewswire)

P1 data • Ulcerative Colitis

A Study of AC-101 Tablets in Patients With Ulcerative Colitis (clinicaltrials.gov) - P2 | N=153 | Not yet recruiting | Sponsor: Accro Bioscience (Suzhou) Limited

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

Accro Bioscience Announces $50 Million Series C Financing Led by OrbiMed to Advance Clinical Pipeline for Immune Mediated Diseases (PRNewswire) - "Proceeds from the financing will fund the Phase IIb clinical trial of AC-101, a leading RIPK2 inhibitor, for the treatment of Ulcerative Colitis (UC), and other novel therapeutic candidates for I&I diseases."

Financing • Ulcerative Colitis

Phase I clinical study of AC-101 tablets (ChiCTR) - P1 | N=32 | Completed | Sponsor: The Second Affiliated Hospital of Anhui Medical University; Accro Bioscience (Suzhou) Limited | Recruiting ➔ Completed

Trial completion • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

A Study of AC-101 Tablets in Participants With Moderate to Severe Active Ulcerative Colitis (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: Accro Bioscience (Suzhou) Limited

New P1/2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Accropeutics Secured $12 Million in Series B Plus Financing (PRNewswire) - "The proceeds from the Series B Plus financing will be used to generate more clinical data for AC-101, a RIPK2 inhibitor, in an ongoing Phase Ib clinical trial for patients with Ulcerative Colitis (UC). Accropeutics' other clinical-stage assets include AC-201, a selective TYK2/JAK1 inhibitor, currently in an ongoing Phase II trial for patients with moderate-to-severe Psoriasis, and for multiple additional indications; and AC-003, a RIPK1 inhibitor, currently in an ongoing Phase Ib trial for patients with acute Graft-versus-Host Disease (aGvHD). The company also has multiple I&I assets in the pre-clinical stage."

Financing • Acute Graft versus Host Disease • Psoriasis • Ulcerative Colitis

Accropeutics Announces First Patient Dosed in Phase Ib Study of RIPK2 Inhibitor AC-101 (PRNewswire) - "Accropeutics Inc...today announced the dosing of their first patient in the Phase Ib clinical trial of AC-101. AC-101 is a novel RIPK2 inhibitor being developed for the treatment of moderate-to-severe Ulcerative Colitis (UC). This multi-center, open-label clinical trial will evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics of AC-101 in Chinese patients with moderate-to-severe UC."

Trial status • Ulcerative Colitis

Accropeutics Inc. Announces U.S. FDA Clearance of IND Application for RIPK2 Inhibitor AC-101 (PRNewswire) - "Accropeutics Inc...today announces that its RIPK2 inhibitor AC-101 has received clearance from the U.S. FDA for a Phase II clinical trial for the treatment of Ulcerative Colitis (UC). The Phase II trial will be a 12-week, multi-regional, randomized, double-blind, placebo-controlled, parallel group clinical trial, to evaluate the safety and efficacy of AC-101 in patients with moderate-to-severe Ulcerative Colitis (UC). Separately, a 12-week, multi-center, open-label, parallel group Phase Ib study of AC-101 in patients with moderate-to-severe Ulcerative Colitis (UC) has been initiated in China."

IND • Trial status • Ulcerative Colitis

Phase I clinical study of AC-101 tablets (ChiCTR) - P1 | N=32 | Recruiting | Sponsor: The Second Affiliated Hospital of Anhui Medical University; Accro Bioscience (Suzhou) Limited

New P1 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

A Study to Evaluate the Effects of Food on Pharmacokinetics of AC-101 (ANZCTR) - P1 | N=12 | Active, not recruiting | Sponsor: Accro Bioscience (Australia) Pty Ltd | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

Part 1 and Part 3: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of AC-101 (ANZCTR) - P1 | N=70 | Active, not recruiting | Sponsor: Accro Bioscience (Australia) Pty Ltd | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

Part 1 and Part 3: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of AC-101 (ANZCTR) - P1 | N=70 | Not yet recruiting | Sponsor: Accro Bioscience (Australia) Pty Ltd

New P1 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

A Study to Evaluate the Effects of Food on Pharmacokinetics of AC-101 (ANZCTR) - P1 | N=12 | Not yet recruiting | Sponsor: Accro Bioscience (Australia) Pty Ltd

New P1 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease