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Octreotide

What it is. What the evidence says.

A prescription medicine that imitates somatostatin, a hormone that turns down certain hormone and digestive signals.

Strong EvidenceApproved Medicine

Predominant research setting. Clinical confidence is claim-specific.

Updated Scientific review pending
Start with the basics Regulatory status ↓
Sequence diagram and chemical structure information for Octreotide.
Octreotide Chemical Structure & Sequence · Inside Peptides Scientific Library
Compound
Octreotide Acetate
Human effectiveness
Extensively documented in multicenter trials over four decades of global clinical use
Regulatory status
FDA-Approved Medicine
START HERE · PLAIN LANGUAGE

Octreotide: the basics

What is it?

A prescription medicine that imitates somatostatin, a hormone that turns down certain hormone and digestive signals.

Research paper ↗

What do people claim it helps with?

Control of excess growth hormone and certain hormone-related diarrhea or flushing are established uses. It is not a general inflammation or longevity treatment.

What has research actually shown?

Clinical evidence supports hormone and symptom control in specific endocrine disorders. Studies in selected neuroendocrine tumors also investigate disease control; findings depend on the tumor and formulation.

Research paper ↗

Has this been demonstrated in people?

Demonstrated in people, including controlled clinical trials for the uses described here. Evidence for one diagnosis does not establish benefit for every other claim.

Research paper ↗

What side effects, risks and unknowns should I understand?

Digestive symptoms, gallstones, changes in blood sugar and slower heart rate can occur. Thyroid function and nutrient absorption may need monitoring.

Prescribing information ↗

Is it an approved medicine?

Yes. Octreotide products have FDA-approved uses including acromegaly and certain symptoms from carcinoid tumors or VIP-secreting tumors; indications differ by product.

Prescribing information ↗

Approval here means U.S. FDA approval and applies to a particular product, formulation and use. This is a starting overview, not a complete side-effect list. Sources checked 10 October 2026; independent scientific review pending.

How is it used or studied?

Prescription short-acting or long-acting formulations; a specialist selects the appropriate product.

Different routes and formulations can have different effects. A study of one product does not validate every product with the same peptide name.

A common misunderstanding

Controlling a tumor’s hormone symptoms is not the same as curing the tumor.

What should I ask a clinician?
  • What diagnosis or goal are we trying to address, and what established options are available?
  • Was the expected benefit shown in people like me, using this exact product?
  • How could my medicines, health conditions or pregnancy plans affect the risks?
  • What monitoring is needed, and what would tell us the treatment is helping or should be stopped?
What do the research words mean?
Peptide
A short chain of amino acids, the building blocks of proteins.
Preclinical
Research in cells, tissues or animals before dependable treatment evidence in people.
Controlled trial
A study comparing a treatment with another treatment or a placebo to help separate its effects from other explanations.
Biomarker
A measurement, such as a hormone level. A change does not necessarily mean someone feels better or lives longer.
THE AVAILABLE RESEARCH

Octreotide Evidence & Clinical Profile

Human Clinical Evidence

Established Clinical Trials

Octreotide has been investigated in clinical contexts. Patient outcomes must be evaluated against study size, design, and control cohorts.

Preclinical & Pharmacological Data

Laboratory & In Vivo Assays

Cellular and animal disease models examine receptor binding affinities and signaling cascades, which require human confirmation.

Understand our evidence labels →

IDENTITY & STRUCTURE

What is Octreotide?

Octreotide Acetate (Sandostatin) is An FDA-approved synthetic cyclic octapeptide somatostatin analogue. Engineered with D-amino acids and an internal disulfide bridge to resist enzymatic degradation, providing potent suppression of growth hormone, glucagon, insulin, and gastroenteropancreatic peptides. Aliases include: Sandostatin, Sandostatin LAR, SMS 201-995.

Chemical sequence and molecular parameters of Octreotide
Primary sequence schematic · Inside Peptides Molecular Database
Chemical reference
Sequence (one-letter)
D-Phe-c[Cys-Phe-D-Trp-Lys-Thr-Cys]-Thr-ol
Molecular formula
C49H66N10O10S2
Molecular weight
1019.2 g/mol
CAS Number
83150-76-9
UNII Code
RWM8CCW8GP
PubChem CID
448601

Identifiers checked against PubChem and FDA's Global Substance Registration System on 13 October 2026. FDA substance record ↗ · PubChem record ↗ See all names and codes in the peptide name index.

HUMAN RESEARCH

Clinical Trials & Human Cohorts

Human research can examine tolerability, symptoms or patient outcomes. The design and comparator determine what each result can establish.

Double-blind Phase 3 RCT2009

Placebo-Controlled Trial of Octreotide LAR in Gastroenteropancreatic Neuroendocrine Tumors [1]

n = 85

What was reported

Statistically significant prolongation of median time to tumor progression (14.3 months vs 6 months) in metastatic midgut NETs.

What limits the conclusion

Report based on a planned interim analysis; too few deaths for the survival analysis to be confirmatory.

Read primary source ↗ (external website)
Single-arm treatment cohort (12-24 months)2001

Long-Term Effects of Depot Octreotide on Hormone Levels and Tumor Mass in Acromegaly [2]

n = 3636 patients with active acromegaly (15 de novo, 21 after unsuccessful surgery)

What was reported

At last follow-up GH was controlled in 69.4% and IGF-I normalized in 61.1%; tumor volume decreased in 12 of 15 de novo patients.

What limits the conclusion

Small uncontrolled series with no comparator arm.

Read primary source ↗ (external website)
MECHANISMS OF ACTION

How the compound may work

Mechanisms describe how Octreotide may affect biological processes. Laboratory findings and patient outcomes answer different questions.

01
Somatotroph and endocrine cells

Somatostatin Receptor Subtype Selectivity (SSTR2/SSTR5)

High-affinity binding to Gi-protein coupled SSTR2 and SSTR5 inhibits adenylyl cyclase and closes voltage-gated Ca2+ channels, blocking exocytosis. [3]

02
Vascular smooth muscle

Splanchnic Vasoconstriction

Suppresses vasodilatory GI peptides (glucagon, VIP), decreasing splanchnic blood flow and reducing portal venous pressure in bleeding varices. [3]

RESEARCH AREAS

Areas Being Studied

These research topics reflect active areas of scientific exploration, distinct from unverified commercial marketing claims.

Phase 3 clinical trials

Acromegaly & Pituitary Adenomas

Endogenous growth hormone and IGF-1 biochemical normalization. [2]

PROMID Phase 3 Trial

Neuroendocrine Tumors (NETs)

Carcinoid syndrome symptom control and antiproliferative tumor stabilization. [1]

Emergency medicine RCTs

Acute Esophageal Variceal Bleeding

Portal pressure reduction and acute hemostasis. [3]

AT A GLANCE

Compare the study designs.

Overview of Key Octreotide Studies: clinical and preclinical records
Study Design / sample Outcome type Key limitation
PROMID Phase 3 NET Trial · 2009 [1] Double-blind Phase 3 RCT
n = 85		 Clinical endpoint evaluation Report based on a planned interim analysis; too few deaths for the survival analysis to be confirmatory.
Acromegaly Long-Term Cohort · 2001 [2] Single-arm treatment cohort (12-24 months)
n = 36		 Clinical endpoint evaluation Small uncontrolled series with no comparator arm.
FDA & SAFETY

Regulatory Status & Clinical Safety

Regulatory Classification

FDA approved: Sandostatin (NDA 019667), Sandostatin LAR depot (NDA 021008), and generic formulations.

Safety Realities & Impurities

Safety depends on the molecule, formulation, route and evidence. A laboratory purity measurement alone cannot establish safety for human use.

REGISTRY CHECK

Clinical Trials Registry Records

Official registry records from ClinicalTrials.gov. Study registration does not imply government endorsement or guaranteed efficacy.

COMPETITIVE SPORT

WADA & Anti-Doping Regulations

Not Prohibited

WADA Anti-Doping Status

Octreotide is not prohibited under current World Anti-Doping Agency (WADA) regulations. However, athletes must ensure unregulated preparations or unverified vendor products do not violate Section S0 (Non-approved substances). Last verified: October 2026.

SELECTED MILESTONES

Research Timeline

  1. 1979

    Synthesis

    Bauer and colleagues synthesize SMS 201-995 at Sandoz. [3]

  2. 1988

    FDA Approval: Sandostatin

    FDA approves Sandostatin injection (NDA 019667). [4]

  3. 1998

    FDA Approval: Sandostatin LAR

    FDA approves the long-acting Sandostatin LAR Depot formulation (NDA 021008). [5]

  4. 2009

    PROMID Trial Landmark

    PROMID reports longer time to tumor progression with octreotide LAR than placebo in metastatic midgut neuroendocrine tumors. [1]

OPEN QUESTIONS

What Researchers Still Don't Know

Long-term safety profiles

Multi-year observational data in broader heterogeneous cohorts remains uncharacterized.

Optimal dose-response thresholds

Comparative trials optimizing minimal effective exposure versus adverse event rates.

Formulation bioavailability

Differences between oral, subcutaneous, and modified peptide delivery vehicles.

TRACEABLE SOURCES

References

Primary sources verified against PubMed / NLM and regulatory databases.

  1. Landmark RCT

    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 (PROMID) ↗ (external website)

    Rinke A et al. · J Clin Oncol · 2009
  2. Clinical Cohort

    Long-term effects of depot long-acting somatostatin analog octreotide on hormone levels and tumor mass in acromegaly ↗ (external website)

    Colao A et al. · J Clin Endocrinol Metab · 2001
  3. Review

    Octreotide ↗ (external website)

    Lamberts SW et al. · N Engl J Med · 1996
  4. Regulatory

    Drugs@FDA: Sandostatin (octreotide acetate injection), NDA 019667 ↗ (external website)

    U.S. Food and Drug Administration · undefined
  5. Regulatory

    Drugs@FDA: Sandostatin LAR Depot, NDA 021008 ↗ (external website)

    U.S. Food and Drug Administration · undefined