CRISPR: 150+ Active Clinical Trials
From 1 approved therapy to 150+ trials across cancer, autoimmune disease, cardiovascular risk, and bespoke rare disease cures.
Explore this event on the interactive timeline →By May 2026, CRISPR gene editing has exploded from a single FDA-approved therapy (Casgevy, 2023) to over 150 active clinical trials. The FDA created a new "plausible mechanism" fast-track pathway specifically for personalized CRISPR therapies (Feb 2026). Trials now cover cancers, autoimmune diseases (lupus remissions achieved), cardiovascular disease (in vivo liver gene editing), and even bespoke one-patient therapies for infants with rare genetic disorders.
Key Numbers
- Active Clinical Trials
- 150+
- FDA-Approved
- 1 (Casgevy)
- New FDA Fast-Track
- Feb 2026
- Diseases Targeted
- Cancer, Autoimmune, CVD, Rare
Verified Facts
- The FDA released a new "plausible mechanism" framework in February 2026, streamlining approval for personalized CRISPR therapies—allowing small patient numbers to support broad applications.
- Zugo-cel (CRISPR Therapeutics): CRISPR-edited CAR-T cells are achieving lupus remissions in clinical trials—the first gene-edited autoimmune treatment.
- CTX310: In vivo CRISPR therapy targeting the ANGPTL3 gene in the liver for severe cardiovascular disease. No surgery—lipid nanoparticles deliver CRISPR directly into the bloodstream.
- Prime editing (next-gen CRISPR, no double-strand DNA breaks) showed positive clinical results for chronic granulomatous disease in 2025-2026.
- Bespoke milestone: A custom CRISPR therapy was designed and delivered to an infant with CPS1 deficiency within 6 months—from diagnosis to treatment. Personalized genomic medicine is arriving.
- This validates Kurzweil's "G Revolution": biology is becoming an information technology—reprogrammable, debuggable, and personalized.