An AI-optimized antibody for severe asthma is in Phase 3 — no AI-designed antibody has been approved.

Generate:Biomedicines' GB-0895 started the placebo-controlled SOLAIRIA-1 Phase 3 study on December 3, 2025 (786 patients planned, dosed every six months, primary endpoint annualized exacerbation rate over 52 weeks); a companion SOLAIRIA-2 study is listed by the sponsor.

What would change this

Phase 3 primary endpoint result; then approval; then treated patients.

Sources

• primaryClinicalTrials.gov NCT07276724 (SOLAIRIA-1)clinicaltrials.gov
• primaryClinicalTrials.gov NCT07359846 (SOLAIRIA-2)clinicaltrials.gov
• secondaryIntuitionLabs: AI-discovered drugs in clinical trials 2026intuitionlabs.ai

Editor's notes

The earlier headline's ~1,600 patients did not match SOLAIRIA-1's registry (786 planned). SOLAIRIA-2 (NCT07359846) is a second 786-patient Phase 3 with the same 52-week exacerbation endpoint, started 20 January 2026, primary completion estimated January 2029, so ~1,600 was the two studies combined (1,572).

Related

• The first generative-AI-discovered drug entered Phase III in September 2026 — no AI-discovered drug has yet been approved anywhere.

History

• Oct 23, 2026Verified the SOLAIRIA-2 registry record (NCT07359846, 786 planned, started 20 Jan 2026) and added it as primary; this closes the verify note. The editor's review is still outstanding, so the entry stays unreviewed.
• Oct 22, 2026The editor has not yet read the registry record; published unreviewed.
• Oct 22, 2026Weekly run: ClinicalTrials.gov primary added (entry now renders); headline patient count removed — registry shows 786 planned for SOLAIRIA-1, not ~1,600.
• Oct 22, 2026Added.

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