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Del-zota (delpacibart zotadirsen)

by NovartisCH

Restore dystrophin reading frame in exon-44 DMD patients.

PilotStage 3 of 5

Under FDA priority review for accelerated approval since Sep 2026; Phase 3 confirmatory trial underway.

Updated Sep 2026Checked 11 Oct0 updates this week

Milestones

Next · Phase 3 SAFARI44 confirmatory trial
  1. Phase 1/2 EXPLORE44 trial positive results2025Complete.
  2. BLA accepted with priority review (accelerated approval)8 Sep 2026Complete.
  3. Phase 3 SAFARI44 confirmatory trialTarget 2026Current milestone.

Most important, last 3 months

Upcoming

  1. 2026Phase 3 SAFARI44 confirmatory trial (next)
Primer