Octreotide

Research overview

Key studies

1. Rinke et al., J Clin Oncol (PROMID) (2009)

   Placebo-controlled, double-blind, randomized phase IIIB, interim analysis
   Model: Humans (85 people with treatment-naive well-differentiated metastatic midgut NETs)

   Median time to progression 14.3 versus 6 months (HR 0.34; 95% CI 0.20-0.59); stable disease at 6 months 66.7% versus 37.2%; survival analysis not confirmatory (HR 0.81) ^4.

2. Samson et al., J Clin Endocrinol Metab (CHIASMA OPTIMAL, NCT03252353) (2020)

   Phase 3, double-blind, placebo-controlled, 36 weeks
   Model: Humans (56 adults with acromegaly controlled on injectable SRLs)

   IGF-1 normalization maintained in 58.2% versus 19.4% (P = .008); median time to loss of response 16 weeks with placebo, not reached with oral octreotide ^5.

3. Sandostatin prescribing information, adverse reactions (2026)

   Pooled clinical-trial safety data
   Model: Humans (mainly acromegaly and psoriasis trials)

   Biliary tract abnormalities 63% (27% gallstones, 24% sludge, 12% duct dilatation); in acromegaly, sinus bradycardia 25% and hyperglycemia 16% ^1.

Dosing as stated on the FDA label

Quoted from the prescribing information for reference. Prescribing decisions belong to a licensed clinician; this is not a recommendation or instruction for use.

• Acromegaly (Sandostatin Injection): initial 50 mcg three times daily subcutaneously, titrated to GH or IGF-1; most common dosage 100 mcg three times daily, with some patients requiring up to 500 mcg three times daily ^1.
• Carcinoid tumors (Sandostatin Injection): 100 to 600 mcg/day in two to four divided doses during the first 2 weeks; experience above 750 mcg/day is limited ^1.
• VIPomas (Sandostatin Injection): 200 to 300 mcg/day in two to four divided doses during the first 2 weeks (range 150 to 750 mcg) ^1.
• Sandostatin LAR Depot: acromegaly, 20 mg intragluteally every 4 weeks for 3 months after 2 weeks of the injection; carcinoid tumors and VIPomas, 20 mg every 4 weeks for 2 months; dosages above 30 mg are not recommended ^2.
• Mycapssa: 40 mg daily as 20 mg twice daily on an empty stomach, titrated in 20 mg increments to a maximum of 80 mg daily; 20 mg once daily to start in end-stage renal disease ^3.

Published adverse-event data

Reported in the cited trials or product labels. Frequencies apply to the stated population and do not transfer to other settings.

• Gallbladder abnormalities (stones, sludge, duct dilatation)
  63% overall (27% gallstones, 24% sludge without stones, 12% biliary duct dilatation)
  Clinical trials, primarily acromegaly or psoriasis ¹ · Complications include cholecystitis, cholangitis and pancreatitis
• Sinus bradycardia (below 50 bpm)
  25%; conduction abnormalities 10%, arrhythmias 9%
  Patients with acromegaly ¹ · Warning-level
• Diarrhea, loose stools, nausea, abdominal discomfort
  Each 34% to 61% in acromegaly; 5% to 10% in carcinoid tumors and VIPomas
  U.S. studies ¹ · 2.6% discontinued
• Hyperglycemia / hypoglycemia
  16% / 3% in acromegaly; about 1.5% in other patients
  Label trials ¹ · Usually mild; may cause overt diabetes
• Hypothyroidism
  Biochemical hypothyroidism 12%, goiter 8%, 4% needed thyroid replacement
  Patients with acromegaly ¹ · Monitor thyroid function
• Injection-site pain, headache, dizziness
  7.7%, 6%, 5%
  Label trials ¹ · Not graded

What is not known: The Sandostatin label states that trials were not designed to show improvement in clinical signs, tumor size or growth rate ^1. PROMID's overall survival result was not confirmatory because of few deaths ^4.

Regulatory status

Status

FDA-approved (initial U.S. approval 1988) as Sandostatin Injection (subcutaneous or intravenous) for acromegaly, metastatic carcinoid tumors and VIPomas; Sandostatin LAR Depot (intramuscular, every 4 weeks) for patients who responded to and tolerated the injection; and Mycapssa (oral) for long-term acromegaly maintenance after response to octreotide or lanreotide. The Sandostatin label states that trials did not show improvement in tumor size or growth rate ^1,2,3.

United States (FDA)

FDA-approved (initial U.S. approval 1988) as Sandostatin Injection, Sandostatin LAR Depot and Mycapssa; labels reviewed from DailyMed versions dated July 2026, December 2025 and July 2025 ^1,2,3.

Sport (WADA)

Octreotide is not named in the 2026 Prohibited List text reviewed; as an approved drug it falls outside S0, but the list's classes include substances with similar biological effects, so status should be confirmed with the relevant anti-doping organization ^6.

Status varies by country and changes over time. How we describe regulatory status.

References

1. SANDOSTATIN (octreotide acetate) injection, prescribing information (DailyMed SPL version 23, published Jul 24, 2026) FDA label (DailyMed). 2026
2. SANDOSTATIN LAR DEPOT (octreotide acetate) for injectable suspension, prescribing information (DailyMed SPL version 29, published Dec 23, 2025) FDA label (DailyMed). 2025
3. MYCAPSSA (octreotide) delayed-release capsules, prescribing information (DailyMed SPL version 6, published Jul 28, 2025) FDA label (DailyMed). 2025
4. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group J Clin Oncol. 2009
5. Maintenance of Acromegaly Control in Patients Switching From Injectable Somatostatin Receptor Ligands to Oral Octreotide J Clin Endocrinol Metab. 2020
6. Tractatenblad 2026 Nr. 25: Anti-doping convention (ETS No. 135), amendment to the appendix - The 2026 Prohibited List, World Anti-Doping Code (English text; entry into force 1 January 2026) Tractatenblad van het Koninkrijk der Nederlanden (official government publication). 2026
7. PubChem compound record for octreotide (CID 448601) PubChem. 2026