Safety and efficacy of once-daily oral paltusotine in acromegaly: ACROBAT Advance open-label extension up to 4 years
Authors' conclusion
Once-daily oral paltusotine treatment was well tolerated and resulted in long-term disease control, including biochemical, symptom, and pituitary tumor stability, for up to 4 years.
Study context
- Population
- Patients with acromegaly previously on an injected somatostatin receptor ligand (SRL)-based regimen who completed phase 2 parent studies ACROBAT Edge or ACROBAT Evolve88% of eligible
- Participants
- 43 patients
- Outcome
- IGF-1 level (×ULN)
- Follow-up
- Up to year 4
Methodological detailsongoing, interim analysis
- Ongoing
- Interim analysis
Main finding
As reported in the abstract
Parent study baseline (n = 43): median (IQR)
1.15×ULN
0.84, 1.46
Advance week 3 (n = 43): median (IQR)
1.17×ULN
0.98, 1.54
Advance week 207 (n = 20): median (IQR)
1.01×ULN
0.83, 1.13
Further findings
- GH levels, acromegaly symptoms and pituitary tumour size remained stable
Safety
Tolerability and discontinuation
- Discontinued from study
- 8 (18.6%)
- Discontinued due to adverse events
- 2 (4.7%)
- Well tolerated, no unexpected safety findings
Original publication
Safety and efficacy of once-daily oral paltusotine in acromegaly: ACROBAT Advance open-label extension up to 4 years. J Clin Endocrinol Metab. Published 26 June 2026. doi:10.
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