Trial Registered

Shanghai Ark starts Phase 3 of AK3280 against pirfenidone in IPF

The new randomized trial pits AK3280 head-to-head with pirfenidone as at least seven other China-based IPF programs also chase forced vital capacity gains.

Shanghai Ark Biopharmaceutical registered a Phase 3 trial of AK3280 in idiopathic pulmonary fibrosis, testing the drug against placebo and pirfenidone with change in forced vital capacity at 52 weeks as the primary measure.

By AppliedXLJuly 22, 2026Trial NCT07719023

Executive Summary

Shanghai Ark Biopharmaceutical Co., Ltd. registered a Phase 3 study of AK3280 in idiopathic pulmonary fibrosis, structured as a randomized, quadruple-masked comparison against both placebo and pirfenidone, an approved antifibrotic.
The registration sets a 52-week lung-function endpoint as the measure that will decide whether AK3280 can compete with existing oral antifibrotics rather than simply demonstrating activity against placebo.
AK3280 enters a China-centered idiopathic pulmonary fibrosis field already carrying several late-stage entrants pursuing the same lung-function endpoint, so its readthrough value comes from timing and design choices rather than novel biology.
Shanghai Ark's own completion track record and the trial's early Not yet recruiting status mean the near-term signal is about program initiation, not yet about clinical performance.

The registration

Shanghai Ark Biopharmaceutical Co., Ltd. filed a new Phase 3 trial, NCT07719023, testing AK3280 in patients with idiopathic pulmonary fibrosis. The study is randomized, quadruple-masked, and structured across three arms with a planned enrollment of 263 patients across sites in China. It targets a primary completion date of September 30, 2028, and full completion by March 31, 2029, with an anticipated start date of August 31, 2026. The trial is not yet recruiting. NCT07719023

The endpoint

The registered primary endpoint is the absolute change from baseline in forced vital capacity (FVC, a measure of lung volume) at week 52. Secondary measures include hemoglobin-corrected diffusing capacity, the six-minute walk distance, a fibrosing lung disease quality-of-life score, and time to first acute exacerbation, all tracked through week 52. The comparator arm includes pirfenidone, an antifibrotic drug approved for idiopathic pulmonary fibrosis, alongside placebo. That design means AK3280 will be judged against an active standard-of-care agent, not placebo alone. NCT07719023

Prior evidence

AK3280 has one earlier trial on record, a Phase 2 placebo-controlled study (NCT05424887) enrolling 105 patients with a 2024 primary completion date, which currently carries an Unknown status in the registry. No AK3280 Phase 3 trial has completed to date, so this registration represents the drug's first late-stage test. NCT07719023

The competitive field

The idiopathic pulmonary fibrosis field carries at least eight active or planned trials that this program's landscape scan surfaced, including Sunshine Lake Pharma's HEC585, InSilico Medicine's rentosertib, Beijing Tide Pharmaceutical's TDI01, Boehringer Ingelheim's nerandomilast, and PureTech's deupirfenidone, most sharing the same 52-week FVC-based primary endpoint structure as AK3280. These programs differ across mechanism classes, spanning TGF-beta, TNIK, and PDE4B pathways, rather than converging on one target. Nintedanib and pirfenidone are both approved for idiopathic pulmonary fibrosis and anchor the standard-of-care bar this and other entrants must clear. Against a field with no single dominant mechanism and multiple approved oral options already in use, a result that separates AK3280 from the pirfenidone comparator arm on FVC decline at 52 weeks would be the finding that distinguishes it from same-stage entrants pursuing the identical endpoint.

Sponsor and operational read

Shanghai Ark has completed 12 of 14 trials and terminated 2 across its broader portfolio, and this Phase 3 program is one of two of the sponsor's studies not yet recruiting. The trial's protocol has seen no amendments since registration, and its enrollment target and timeline are described as stable at this early stage. Because the trial has not yet opened enrollment, the near-term signal is limited to design and positioning rather than any early operational deviation. NCT07719023

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.