Insilico Medicine, a clinical-stage biotechnology company focused on generative artificial intelligence–driven drug discovery, has announced the first clinical milestone for its investigational drug ISM4808 after partner TaiGen Biotechnology successfully enrolled and dosed the first participant in a Phase I clinical trial.

The drug candidate is being developed to treat anemia associated with Chronic Kidney Disease (CKD), a condition whose prevalence continues to increase across the Greater China region. Anemia remains one of the most common complications of CKD, affecting more than one in seven patients.

ISM4808 is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PHD) inhibitor discovered using Insilico’s generative chemistry platform, Chemistry42. The therapy is designed to stimulate the body’s natural production of erythropoietin while improving iron metabolism.

Unlike conventional Erythropoiesis-Stimulating Agents, which often require injections, ISM4808 is intended as an oral therapy that may improve iron utilisation and provide a more convenient treatment option with a favourable safety profile.

In December 2025, Insilico Medicine licensed the programme to TaiGen Biotechnology, granting the latter exclusive rights to develop, commercialise and sublicense the therapy across Greater China, including mainland China, Hong Kong, Macau and Taiwan. The agreement includes upfront payments, milestone payments tied to development and sales, and tiered royalties on net sales, with the overall deal value reaching tens of millions of dollars.

Following the licensing agreement, TaiGen rapidly initiated preparations for clinical testing. The Phase I study is designed as a randomised, double-blind, placebo-controlled trial involving both single-ascending-dose and multiple-ascending-dose cohorts to assess the safety, tolerability and pharmacokinetics of ISM4808 in healthy volunteers.

Kuo-Lung Huang, Chairman of TaiGen Biotechnology, said the rapid transition from licensing to first-patient dosing highlights the company’s clinical development capabilities. He added that the therapy could address a major unmet need in the CKD anemia market by offering patients a safer and more convenient oral treatment option.

Feng Ren, Co-Chief Executive Officer and Chief Scientific Officer of Insilico Medicine, noted that the swift clinical progress demonstrates the effectiveness of combining AI-driven early drug discovery with specialised clinical development expertise. He expressed optimism that ISM4808 could deliver meaningful results in trials and eventually provide a differentiated therapy for patients with CKD-related anemia.

The company also continues to advance other AI-discovered drug candidates. One such programme, garutadustat—another PHD-targeting compound discovered using the Chemistry42 platform—is currently being developed by Insilico as a potential treatment for inflammatory bowel disease, with Phase II clinical trials already underway.