AI-Originated Clinical Pipeline

Select AI-discovered or AI-designed drug candidates in clinical development, tracked by phase. As of mid-2026, 173+ AI-originated programs are in clinical trials; no fully AI-discovered drug has yet received FDA approval.

Notable AI-Designed Candidates

CandidateCompanyTarget / ModalityIndicationPhase
Rentosertib
ISM001-055 / INS018_055		 Insilico Medicine TNIK inhibitor (small molecule) Idiopathic pulmonary fibrosis (IPF) Phase III
GTAEXS617
'617		 Exscientia / Recursion CDK7 inhibitor (small molecule) Solid tumours (ovarian, TNBC and others) Phase 1/2
EXS4318
'4318		 Exscientia → BMS PKC-theta inhibitor Autoimmune / inflammatory diseases Phase 1
RLY-2608 Relay Therapeutics PI3Kα inhibitor (mutant-selective) Oncology (PIK3CA-mutant solid tumours) Phase 3
ISM5939 Insilico Medicine ENPP1 inhibitor (oral) Solid tumours (immuno-oncology) Phase 1
ISM001-055 portfolio Insilico Medicine Multiple AI-designed programs Fibrosis, oncology, immunology, metabolism, pain Phase 1–2
Why this matters: Rentosertib is the first fully AI-discovered drug to demonstrate positive Phase IIa efficacy (published in Nature Medicine, 2025) and entered a 320-patient Phase III trial in July 2026. Industry data show AI-designed molecules clear Phase I at roughly 80–90% versus ~52% historically, but Phase II success sits near 40% — so the real test is late-stage. Source: multiple industry analyses, 2026.

Success-Rate Reality Check

Phase I

80–90% success for AI-discovered molecules

vs ~52% historically for conventional candidates.

Source: AI2Work / IntuitionLabs analyses, 2026

Phase II

~40% success for AI-discovered molecules

Statistically indistinguishable from conventional drug development.

Source: AI2Work / IntuitionLabs analyses, 2026

Full FDA approval

0 fully AI-discovered drugs approved (Aug 2026)

~175 AI-originated programs have entered human trials; none have crossed the finish line.

Source: AI2Work, Aug 2026; PMC; intuitionlabs.ai