Octreotide
As of the edition of 20 October 2026, Octreotide is a protein: marketed, first approved in 1988 (CH); acts on SSTR1, SSTR2 and SSTR3 and 2 more; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Protein
- Brand name
- Sandostatin
- First approved
- 15 August 1988 (CH)
- Approvals on record
- 21 in 7 regions
- Holder of the most recent approval
- Camurus; 7 holders in all
- Withdrawn from market
- 26 February 2025 (in some regions)
- Registered trials
- 166, 25 stopped early
- Disease areas
- Cancer; Hormones; Digestive system; Nervous system; Bones, joints and muscles; Nutrition and metabolism
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Chiesi Farmaceutici holds a later exclusivity on its own new formulation or combination product, ending 2027; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
5 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product5 company-target rows are on route B because of Octreotide.
See the 5 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 26 | 17 | 3 | 2 |
| Phase 1 | 22 | 17 | 1 | 3 |
| Phase 2 | 55 | 36 | 1 | 11 |
| Phase 3 | 37 | 23 | 9 | 5 |
| Phase 4 | 26 | 19 | 0 | 4 |
| All trials | 166 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Applicant and Lead sponsor of trials | 1988 to now |
| Amryt Pharma | Later holder and Lead sponsor of trials | 2012 to now |
| Camurus | Applicant and Lead sponsor of trials | 2015 to now |
| Chiesi Farmaceutici | Acquired holder | 2024 to now |
| SUN Pharmaceutical Industries | Later holder | 2024 to now |