Octreotide official document review · version 1
This page preserves this version's findings, scope and source pins. Open the current profile →
Inside the official reviews
Reviewed 2026-09-19 · Preserved version 1
The oral formulation was tested for maintenance
FDA’s 2020 review evaluated oral octreotide in people whose acromegaly was already controlled with injectable octreotide or lanreotide. The randomized placebo-controlled study tested maintenance of biochemical control over 36 weeks. FDA PDF pp. 3, 4 ↗
More findings, study links and document coverage
The endpoint was biochemical control
More participants maintained the specified IGF-1 threshold with oral octreotide than placebo. IGF-1 and growth-hormone measures are distinct from directly measuring survival or every symptom in this trial. FDA PDF pp. 3, 5 ↗
Prior response defined who was studied
The review restricted its conclusion to people who had responded to and tolerated octreotide or lanreotide. No participants previously controlled with pasireotide were enrolled, leaving that switch unanswered. FDA PDF pp. 4, 5 ↗
Oral administration did not remove class-related harms
Gastrointestinal, gallbladder and glucose abnormalities were reported. FDA found the safety pattern consistent with the somatostatin-analogue class; that does not mean the oral formulation was free of adverse effects. FDA PDF pp. 4, 6 ↗
Read the separate U.S. label account → Label version and indication scope are preserved there; these agency reviews describe their own dated evidence.
Document coverage
Selected sections read in 1 of 1 inventoried documents; 0 not yet reviewed. Reading selected sections does not establish complete appraisal of a document.
One selected official document from the retained EMA document inventory or an independently retrieved FDA application package. Other formulations, later variations, national records and the wider source inventory remain outside this reading. EMA inventory source ↗
Inspect documents, application identities and source pins
Page references use one-based PDF file pages, which can differ from printed page numbers. Candidate feed associations are not verified application identities.
Mycapssa: FDA selected application review ↗
Selected sections reviewed · fda-octreotide-review-2020 · Document/feed date: 2020-06-23
Application identity and document date were checked in the PDF, independently of the URL year or candidate feed association.
Verified: Mycapssa · NDA 208232 · Document dated 2020-06-23. Identity checked on PDF pp. 2.
Selected identity, clinical-summary and benefit-risk sections only; this is not a full-document or all-indication appraisal.
Retrieved 2026-09-19. Read PDF pages: 2, 3, 4, 5, 6 of 32. SHA-256:
5d3d903a45a1716927050991fc46b70790be4a156694e41988ce9e15b9b5c94c.
Remaining work
- Review the injectable octreotide programs separately from oral maintenance therapy.
- Appraise oral extension reports and later comparative studies with prior-response selection preserved.