Track octreotide in Peptimes™
Octreotide is a cyclic octapeptide with actions that mimic those of the natural hormone somatostatin. It is the active ingredient in Sandostatin, Sandostatin LAR Depot, Bynfezia Pen, Mycapssa and generic octreotide injections. (Source: DailyMed label.)
Is octreotide FDA-approved?
Yes, as specific products: Sandostatin, Sandostatin LAR Depot, Bynfezia Pen, Mycapssa capsules and generic octreotide injections are FDA-approved, by prescription, for the uses in their labels.
Octreotide
Also: Sandostatin, Sandostatin LAR Depot, Bynfezia, Mycapssa, octreotide acetate, SMS 201-995
- Status label in the Peptimes Library
- FDA Approved
- Routes in Peptimes
- SubcutaneousIntramuscularOralOther
- Updated
- 1 Nov 2026
US regulatory status
FDA approval belongs to each product below, for its route and the uses in its label. Label uses are shortened unless quoted.
Sandostatin (octreotide acetate) injection
Subcutaneous or intravenous
Acromegaly, in the patients the label defines; severe diarrhea and flushing from metastatic carcinoid tumors; and watery diarrhea from vasoactive intestinal peptide tumors (VIPomas).
Source: DailyMed label, checked 1 Nov 2026
Sandostatin LAR Depot (octreotide acetate) for injectable suspension
Intramuscular (into the buttock)
Long-term treatment of the same three conditions, in patients who have responded to and tolerated Sandostatin injection.
Source: DailyMed label, checked 1 Nov 2026
Bynfezia Pen (octreotide acetate) injection
Subcutaneous
Acromegaly, in the patients the label defines; severe diarrhea and flushing from metastatic carcinoid tumors; and watery diarrhea from VIPomas.
Source: DailyMed label, checked 1 Nov 2026
Mycapssa (octreotide) delayed-release capsules
Oral
Long-term maintenance treatment of acromegaly in patients who have responded to and tolerated octreotide or lanreotide.
Source: DailyMed label, checked 1 Nov 2026
Generic octreotide acetate injection, from several manufacturers, with Sandostatin as the reference product
Subcutaneous or intravenous
As stated on each product's label (approved through abbreviated new drug applications, ANDAs).
Source: Drugs@FDA, checked 1 Nov 2026
Investigational
No, for the products and uses above.
Source: Drugs@FDA, checked 1 Nov 2026
What studies have looked at
Each point says who or what was studied and what the study reported, with its source and the date we checked it. These are findings from the sources cited, not advice or a promise of any result.
- In humans
A placebo-controlled trial in 56 people with acromegaly whose levels were controlled on injections: more people kept normal IGF-1 levels on oral octreotide capsules than on placebo, and 3 in 4 of the capsule group finished the trial on oral therapy.
Source: PMID 32882036, checked 1 Nov 2026
How to track it in Peptimes
Add octreotide in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry shows the status label “FDA Approved”; the list above gives the detail by product.
- Routes: subcutaneous, intramuscular, oral or Other (for example intravenous). Choose the one that matches each dose.
- Logging: the amount you took, the route and how you feel.
- Injection sites: subcutaneous and intramuscular doses record the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next. Oral and Other doses skip this step.
- Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the peptide tracker app page.
Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell octreotide or any other compound.
More sources
- FDA, Drugs@FDA: NDA 019667 (Sandostatin), NDA 021008 (Sandostatin LAR), NDA 213224 (Bynfezia Pen) and NDA 208232 (Mycapssa), checked 1 Nov 2026: product, route and marketing status.
- FDA, Global Substance Registration System, Octreotide, checked 1 Nov 2026: the code name SMS 201-995.
Related pages
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