PeptideTrace
ApprovedSomatostatin Analogue

Octreotide

Sandostatin, Sandostatin LAR, Mycapssa

A

Evidence Grade A — Regulatory approved. 9211 published studies. 236 registered clinical trials.

236 trials9,211 studiesUSEUCA

Licensed Indications

  • Acromegaly
  • Carcinoid Tumors
  • Vasoactive Intestinal Peptide Tumors

User Experience Reports

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Overview

Octreotide is a medication that mimics somatostatin — a natural hormone that acts as a brake on many other hormones in the body. It is used for conditions caused by hormone overproduction, including acromegaly (excess growth hormone) and hormone-secreting neuroendocrine tumours. Available as a short-acting injection (Sandostatin), a monthly depot (Sandostatin LAR), and the first-ever oral somatostatin tablet (Mycapssa), it has one of the longest track records of any peptide medication — over 35 years.

Research Activity

9,211studies
Human 6907
Animal 945
In-vitro 816
Reviews 1663

9,211 published studies: 6907 human, 945 animal, 816 in-vitro, 1663 reviews

Regulatory Status

US
FDA-approved(FDA)
EU
EMA-authorised(EMA)
CA
Health Canada approved(Health Canada)

Legal Status

USPrescription drug (Rx)
EUPrescription medicine (EU centralised authorisation)
CAPrescription drug

Summary

Octreotide is marketed as Sandostatin (approved 1988), Sandostatin LAR monthly depot (approved 1998), and Mycapssa oral capsules (approved June 2020 — the first oral somatostatin analogue). It is used for acromegaly, carcinoid syndrome, VIPomas, and gastroenteropancreatic neuroendocrine tumours (GEP-NETs).

The PROMID trial demonstrated that octreotide LAR significantly delayed tumour progression in patients with neuroendocrine tumours of the midgut, establishing somatostatin analogues as a standard treatment for these cancers. The approval of Mycapssa as an oral formulation was a significant advance for patients who had been receiving monthly injections for years. Octreotide has been on the market for over 35 years and has one of the longest safety track records of any peptide medication.

Mechanism of Action

Your body produces somatostatin as a natural 'off switch' for many hormones — it tells the pituitary gland to stop releasing growth hormone, tells the gut to slow hormone secretion, and reduces blood flow to the digestive organs. Octreotide mimics this effect but lasts much longer than the natural hormone (hours rather than minutes). It is particularly effective at suppressing growth hormone in acromegaly and reducing hormone secretion from neuroendocrine tumours, which relieves symptoms like severe flushing and diarrhoea.

Research Summary

Octreotide's evidence base is extensive. The PROMID trial demonstrated that monthly octreotide LAR significantly delayed tumour progression in patients with neuroendocrine tumours of the midgut, establishing somatostatin analogues as a standard first-line treatment for these cancers. For acromegaly, octreotide normalises growth hormone levels in approximately 50-65% of patients. The approval of Mycapssa (oral octreotide capsules) in 2020 was a significant advance for patients who had been receiving monthly injections for years, though the oral form is currently approved only for acromegaly patients already stable on injectable octreotide. Key limitations include gallstone formation (affecting up to 63% of long-term users) and blood sugar elevation. Lanreotide (Somatuline Depot) is considered clinically equivalent and offers home self-injection.

Clinical Trials

NCT00002253N/ACompleted

A Multicenter Placebo-Controlled Double Blind Study to Evaluate the Efficacy and Safety of Sandostatin ( SMS 201-995 ) in Patients With Acquired Immunodeficiency Related Diarrhea Who Were Either "Responders" or "Non-Responders" in a Prior Placebo-Controlled Double-Blind Sandostatin Study.

Sandoz
NCT00227773Phase IIWithdrawn

Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors

Eastern Cooperative Oncology Group
NCT00002252N/ACompleted

A Multicenter Placebo-Controlled Dose Titration Study to Evaluate the Efficacy and Safety of Sandostatin (SMS 201-995) in the Treatment of Patients With Acquired Immunodeficiency Related Diarrhea

Sandoz
NCT02217826Phase ICompleted

Single Dose Pharmacodynamic and Pharmacokinetic Study of DG3173

Aspireo Pharmaceuticals LimitedEndpoint: Concentration of glucose, insulin and glucagon in plasma.
NCT06881888Phase INot Yet Recruiting

Intranasal Delivery of Octreotide for Treatment of Diabetic Macular Edema

University of Alabama at BirminghamEndpoint: Change in macular central subfield thicknessCompletion: 2027-12-01
View all 236 trials on ClinicalTrials.gov →

Regulatory Timeline

1998
Regulatory

FDA ORIG 1

1999
Regulatory

FDA SUPPL 1

1999
Regulatory

FDA SUPPL 2

2001
Regulatory

FDA SUPPL 3

2002
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FDA SUPPL 4

2002
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FDA SUPPL 5

2003
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FDA SUPPL 7

2004
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Health Canada Market Authorisation

2004
Regulatory

FDA SUPPL 10

2004
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FDA SUPPL 6

2004
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FDA SUPPL 15

2005
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FDA ORIG 1

2006
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FDA ORIG 1

2006
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FDA SUPPL 19

2006
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FDA SUPPL 18

2008
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FDA SUPPL 21

2010
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FDA SUPPL 23

2011
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FDA ORIG 1

2011
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FDA SUPPL 1

2011
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FDA SUPPL 25

2011
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FDA SUPPL 2

2012
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FDA SUPPL 13

2012
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FDA SUPPL 11

2012
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FDA SUPPL 5

2012
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FDA SUPPL 27

2013
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FDA SUPPL 3

2013
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FDA ORIG 1

2014
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FDA SUPPL 29

2014
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FDA SUPPL 28

2014
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FDA SUPPL 30

2014
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FDA SUPPL 32

2015
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2016
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2016
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2017
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FDA SUPPL 25

2017
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FDA SUPPL 5

2017
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FDA SUPPL 6

2017
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FDA SUPPL 2

2018
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FDA SUPPL 8

2018
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FDA SUPPL 6

2018
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FDA SUPPL 36

2019
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FDA SUPPL 43

2019
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FDA SUPPL 5

2019
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FDA SUPPL 7

2019
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FDA SUPPL 28

2020
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FDA ORIG 1

2021
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FDA SUPPL 41

2023
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FDA SUPPL 46

2023
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FDA SUPPL 10

2023
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FDA SUPPL 13

2023
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FDA SUPPL 11

2023
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FDA SUPPL 16

2023
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FDA SUPPL 14

2023
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FDA SUPPL 9

2023
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FDA SUPPL 13

2023
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FDA SUPPL 32

2023
Regulatory

FDA SUPPL 35

2023
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FDA SUPPL 33

2023
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FDA ORIG 1

2024
Regulatory

FDA SUPPL 47

2024
Regulatory

FDA ORIG 1

2024
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FDA SUPPL 6

2024
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FDA SUPPL 49

2024
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FDA SUPPL 21

2024
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FDA SUPPL 18

2024
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FDA ORIG 1

2025
Regulatory

EMA Marketing Authorisation

2025
Regulatory

FDA ORIG 1

Related Compounds

Exenatide

Approved
GLP-1 Receptor Agonist

Exenatide was the first GLP-1 receptor agonist approved anywhere, reaching the market as Byetta in April 2005. The once-weekly formulation Bydureon followed in 2012. Clinical trials showed blood sugar reductions (HbA1c) of 1.6–1.9% and modest weight loss of 2–4 kg. The EXSCEL cardiovascular outcomes trial, involving over 14,700 patients, showed a trend toward cardiovascular benefit but narrowly missed statistical significance. While exenatide was groundbreaking as the first in its class, it has been largely overtaken by newer GLP-1 treatments that offer greater efficacy, less frequent dosing, and proven cardiovascular benefits. It remains available and in clinical use, particularly in combination products.

Lixisenatide

Approved
GLP-1 Receptor Agonist

Lixisenatide was marketed as Adlyxin in the US (approved July 2016), though it has since been discontinued in the US market. The ELIXA cardiovascular trial, involving over 6,000 patients, was the first cardiovascular outcomes trial for any GLP-1 medication to report results. It showed a neutral cardiovascular profile — neither harmful nor beneficial — meeting safety requirements but not demonstrating the heart benefits later shown by semaglutide and liraglutide. Lixisenatide found its primary clinical role in combination with basal insulin, marketed as Soliqua (lixisenatide plus insulin glargine). This combination addresses both fasting blood sugar (via insulin) and post-meal spikes (via lixisenatide) in a single daily injection. As a standalone treatment, it has been largely superseded by more potent GLP-1 medications.

Pramlintide

Approved
Amylin Analogue

Pramlintide is marketed as Symlin (approved March 2005) and remains the only approved amylin-based treatment. It is used alongside mealtime insulin in both type 1 and type 2 diabetes. Clinical trials showed modest blood sugar improvements (HbA1c reductions of 0.2–0.6%) and approximately 2.3 kg of weight loss — less dramatic than GLP-1 treatments but meaningful as an add-on therapy. Symlin carries a boxed warning for severe hypoglycaemia, particularly when combined with insulin, and requires careful dose adjustment. Practical uptake has been limited by the need for separate injections at each meal alongside existing insulin injections. Despite its modest clinical impact, pramlintide remains the only medication that addresses the amylin deficiency in diabetes, filling a distinct biological role that GLP-1 treatments do not cover.