Digestive & weight Somatostatin analog
Octreotide
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Octreotide (sold as Sandostatin and, as an oral capsule, Mycapssa) is a synthetic analog of the hormone somatostatin that suppresses growth hormone and a range of gut hormones. It is used to control acromegaly and the symptoms of certain hormone-secreting tumors, including carcinoid syndrome. It has been FDA-approved in the U.S. since 1988 and is available as short-acting injections, a monthly depot, and an oral form.
At a glance
- What it is
- A somatostatin analog peptide that suppresses growth hormone and gut hormones
- Approved for
- Acromegaly, carcinoid syndrome symptoms, and VIPoma-associated diarrhea
- Key fact
- In the PROMID trial, the long-acting depot roughly doubled the time to tumor progression in metastatic midgut neuroendocrine tumors
- Route
- Subcutaneous or intravenous injection, monthly intramuscular depot, or oral capsule
- Evidence strength
- FDA approved
Summary
Octreotide is an FDA-approved somatostatin analog used for acromegaly and hormone-secreting tumors. Learn how it works, its forms, and side effects.
What is octreotide?
Octreotide, sold as Sandostatin, Sandostatin LAR Depot, and the oral capsule Mycapssa, is a synthetic cyclic octapeptide that mimics somatostatin, the body's own hormone that puts the brakes on several endocrine systems. Natural somatostatin is broken down within minutes; octreotide is engineered to last far longer, which makes it practical as a medicine. It was developed under the code SMS 201-995 and approved in the United States in 1988.
How does octreotide work?
Octreotide binds somatostatin receptors, chiefly the subtype 2 receptor, on hormone-secreting cells. Activating those receptors suppresses the release of growth hormone and insulin-like growth factor 1, as well as gut hormones such as serotonin, vasoactive intestinal peptide, and gastrin. By damping that hormone output, octreotide controls the symptoms and biochemistry of conditions driven by hormone excess.
Its effect differs by condition:
| Condition | Effect of octreotide |
|---|---|
| Acromegaly | Suppressing growth hormone and IGF-1 improves symptoms and can shrink pituitary tumors |
| Carcinoid syndrome | Reducing serotonin and related mediators eases flushing and diarrhea |
| VIPoma | Reduces the severe secretory diarrhea |
Somatostatin analogs also have an antiproliferative effect on some neuroendocrine tumors. In the PROMID trial, the long-acting depot lengthened the median time to tumor progression to 14.3 months versus 6.0 months with placebo in metastatic midgut neuroendocrine tumors. Depot and oral formulations allow steady control without multiple daily injections.
Is it FDA-approved?
Editor’s note
Status: Yes. Octreotide was approved by the FDA in 1988 as the short-acting Sandostatin injection, with the monthly Sandostatin LAR Depot following about a decade later and the oral Mycapssa capsule approved in 2020 for maintenance in acromegaly.
Category: FDA-approved · Primary body area: Digestive & weight
Yes. Octreotide was approved by the FDA in 1988 as the short-acting Sandostatin injection, with the monthly Sandostatin LAR Depot following about a decade later and the oral Mycapssa capsule approved in 2020 for maintenance in acromegaly.
What is octreotide prescribed for?
Octreotide is prescribed for acromegaly, for the flushing and diarrhea of carcinoid syndrome, and for the profuse diarrhea of VIPoma. The oral form is used for long-term maintenance in people with acromegaly who have already responded to and tolerated injectable somatostatin analogs.
What are the side effects?
According to the prescribing information, common side effects include:
- Diarrhea, abdominal pain, nausea, and flatulence
- Injection-site pain
- Gallstones or biliary sludge
- High or low blood sugar
More serious considerations include:
- Gallbladder disease with long-term use
- Changes in blood glucose and thyroid function
- Slowed heart rate and cardiac conduction effects
Sources: FDA prescribing information for Sandostatin, Sandostatin LAR, and Mycapssa; the PROMID trial (Rinke et al., Journal of Clinical Oncology, 2009, DOI: 10.1200/JCO.2009.22.8510), indexed on PubMed. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
approved (PDF)
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