Reduced breakthrough symptom exacerbations in patients with biochemically controlled acromegaly switched from injected depot somatostatin receptor ligands to once-daily oral paltusotine in the PATHFNDR-1 clinical trial
Authors' conclusion
In patients with acromegaly biochemically controlled with injected SRLs, switching to once-daily oral paltusotine was associated with stable biochemical control, stable symptom severity, and a significantly reduced frequency of symptom exacerbations.
Study context
- Population
- Patients with acromegaly biochemically controlled (IGF-1 ≤ 1.0× ULN) with somatostatin receptor ligand (SRLs)
- Participants
- 22 patients
- Comparison
- Oral paltusotine vs prior depot SRL injections
- Paltusotinen = 22
- Primary endpoint
- Frequency of breakthrough acromegaly symptom exacerbations (≥ 2-point increase in any individual Acromegaly Symptom Diary symptom score, 2-day average vs prior 2-day average)
Methodological details36-week, randomized, placebo-controlled, double-blind, phase 3
- 36-week
- Randomized
- Placebo-controlled
- Double-blind
- Phase 3
Primary result
As reported in the abstract
Symptom exacerbation frequency (% of days)
P < 0.0001
Further findings
IGF-1 levels and overall core symptom severity
- No significant changes in IGF-1 levels or overall core symptom severity scores
Individual symptom exacerbation frequencies
- Reduction with paltusotine consistent across all acromegaly symptoms assessed
Correlation of IGF-1 with symptoms
- IGF-1 levels did not correlate significantly with symptom severity scores or symptom variability
Original publication
Reduced breakthrough symptom exacerbations in patients with biochemically controlled acromegaly switched from injected depot somatostatin receptor ligands to once-daily oral paltusotine in the PATHFNDR-1 clinical trial. Pituitary. Published 23 July 2026. doi:10.
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