Recursion Clears IND for AI Designed PI3Kα Inhibitor REC 7735

What changed

Recursion Pharmaceuticals reported in its second quarter 2026 results that the U.S. Food and Drug Administration cleared an investigational new drug application for REC-7735, an AI designed PI3Kα H1047R inhibitor. The company plans to initiate the Phase 1/2 ZINNIA study in the second half of 2026 for patients with select PIK3CA H1047R mutant solid tumors.

Recursion said REC-7735 was precision designed for more than 100 fold selectivity for the H1047R mutant over wild type PI3Kα, aiming for sustained target inhibition while limiting hyperinsulinemia driven reactivation. The development candidate was delivered in 10 months and 242 compounds using Recursion's AI native design platform, according to the company's investor release.

Why it matters

AI drug discovery narratives often stop at preclinical slides. An IND cleared oncology candidate with a named mutant selective hypothesis gives R&D and BD teams a concrete milestone to compare against Insilico's China based Phase III rentosertib path and traditional kinase programs. Speed to development candidate matters only if the trial design can test the selective claim in humans.

The Genentech validated neuroscience target option disclosed in the same earnings cycle is a separate proof point for Recursion's map based discovery engine. REC-7735 shows the platform can also compress medicinal chemistry timelines on validated oncology targets with known resistance mechanics.

Who is affected

Oncology clinical development leads tracking PIK3CA mutant portfolios and combination strategies with CDK4/6 or endocrine pathways.

TechBio investors separating platform revenue from asset level readouts as Recursion advances multiple AI originated candidates.

Payers and HTA analysts who will eventually need evidence that mutant selective design translates to tolerability and efficacy versus non selective PI3K inhibitors.

What to do next

Monitor ZINNIA trial registration for inclusion criteria tied to H1047R testing and early safety signals on metabolic reactivation before modeling competitive timelines against other PI3Kα programs.

What to watch

First patient in timing for ZINNIA, initial pharmacokinetic and pharmacodynamic disclosures, and whether Recursion publishes the 242 compound design trajectory in a peer reviewed venue.

Sources

1. Primary. Recursion Pharmaceuticals, Recursion Reports Second Quarter Financial Results; Genentech Options First Neuroscience Target (2026). IND clearance, ZINNIA timeline, selectivity and design cycle statistics.
2. Primary. SEC Exhibit 99.1, Recursion Q2 2026 earnings release (SEC filing). Matching REC-7735 program details and milestone payments from Genentech collaboration.
3. Secondary. Industry trackers on AI originated drug approval gaps (August 2026). Context that REC-7735 remains investigational with no FDA approval.