Reviewed & approved by Dr. Nova Reyes · Last checked 2026-10-25. ← Back to Evidence Library

title: "Octreotide: What the evidence says" slug: octreotide status: Draft (v1), pending review by Dr. Nova Reyes (Batch F #69) last_checked: 2026-10-25 evidence_verdict: "Acromegaly and neuroendocrine tumors (labeled): Strong · Gray-market use: No human data" card_verdict: "Strong (acromegaly, neuroendocrine tumors) · Gray-market: No human data" related: [semaglutide]

Draft (v1), pending review. Not public. · ← Library · DRAFT · not published · last checked 2026-10-25

Octreotide: what the evidence says

At a glance

What it is: a cyclic 8-amino-acid analog of somatostatin, sold as Sandostatin (injection), Sandostatin LAR Depot, Bynfezia Pen, Mycapssa (oral capsules) and generics for acromegaly and hormone-secreting neuroendocrine tumors. ^{R1, R2, R3}

What the evidence says: in a 115-person acromegaly trial it lowered growth hormone and normalized IGF-1 in 55–68% after 6 months. ^R4 In PROMID (midgut neuroendocrine tumors) the long-acting form slowed tumor growth (14.3 vs 6 months to progression). ^R5 Oral capsules kept acromegaly controlled in 58% vs 19% on placebo. ^R6

Biggest risks: gallstones and sludge (biliary abnormalities in 63% in trials), slow heart rate (25% of acromegaly patients), high or low blood sugar, and underactive thyroid. ^R1

Rating


Human Human evidence	Strong for acromegaly and neuroendocrine tumor control ^R4–R6; No human data on gray-market products
Animal Animal / lab evidence	Not reviewed for this page
Regulatory	FDA-approved: Sandostatin NDA 019667 (1988), Sandostatin LAR NDA 021008, Mycapssa NDA 208232, Bynfezia NDA 213224, generics ^R2 · WADA: not named on the 2026 List ^R7
Established human dose	For labeled uses: on the FDA labels ^{R1, R3}. Study details lists what trials used

Evidence verdict: Acromegaly and neuroendocrine tumors (labeled): Strong · Gray-market use: No human data Card verdict: Strong (acromegaly, neuroendocrine tumors) · Gray-market: No human data Card note: Gallstone and heart-rate warnings, see page.

This page reports what studies used. It is not dosing advice.

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source

About the evidence: the oral-capsule trial was run by the developer, Chiasma ^R6; PROMID was an academic German study group. ^R5

What is it?

Octreotide mimics somatostatin, which switches off growth hormone and many gut hormones; it lasts much longer than the natural hormone. ^R1 Hospital use for acute variceal GI bleeding is off-label in the US (not among the FDA-labeled indications on the Sandostatin or Mycapssa labels). ^R1–R3

Does it work?

Human Acromegaly (Ezzat 1992): 115 patients: IGF-1 normal in 68% and 55% on the two amounts at 6 months; pituitary tumor shrank in 19–37%. ^R4
Human Midgut NETs (PROMID): time to progression 14.3 vs 6 months (HR 0.34); survival not confirmatory. ^R5
Human Oral octreotide (OPTIMAL): 56 patients: IGF-1 control kept in 58.2% vs 19.4%. ^R6

Is it safe?

Human Gallbladder: biliary abnormalities 63% (27% gallstones) in trials; <2% with 1 month or less. ^R1
Human Heart: bradycardia 25%, conduction abnormalities 10%, arrhythmias 9% in acromegaly patients. ^R1
Human Glucose and thyroid: hyperglycemia 16%, hypoglycemia 3%; hypothyroidism. ^R1

Gray-market "research use only" Octreotide: extra risks

Not the approved product. Gray-market octreotide has unknown identity, strength and sterility. Unknown No human studies have evaluated gray-market octreotide products.

What we don't know

Unknown Quality of gray-market products

Is it legal?

US: FDA-approved (Sandostatin NDA 019667; Sandostatin LAR Depot NDA 021008; Mycapssa NDA 208232; Bynfezia Pen NDA 213224; generic ANDAs) for acromegaly and carcinoid/VIPoma symptoms (injectables) and maintenance in acromegaly (Mycapssa). ^{R1, R2, R3} EU, UK and others: UNVERIFIED. WADA: not named on the 2026 Prohibited List. ^R7

Study details

These are amounts researchers used, not recommendations. ### R4 Human RCT: acromegaly (Ezzat 1992) | Study | People / model | Route | Amount used | Follow-up | Reported | Side effects / limitations | Citation | |---|---|---|---|---|---|---|---| | Ezzat 1992 | 115 adults with acromegaly | Subcutaneous | 100 or 250 mcg every 8 hours | 6 months | IGF-1 normal 68% / 55% | Older trial | [PMID 1416572](https://pubmed.ncbi.nlm.nih.gov/1416572/) | ### R5 Human RCT: PROMID (Rinke 2009) | Study | People / model | Route | Amount used | Follow-up | Reported | Side effects / limitations | Citation | |---|---|---|---|---|---|---|---| | Rinke 2009 | Treatment-naive metastatic midgut NETs [count not in abstract] | Intramuscular LAR | 30 mg monthly | Until progression | TTP 14.3 vs 6 months | Few deaths; survival not confirmatory | [PMID 19704057](https://pubmed.ncbi.nlm.nih.gov/19704057/) | ### R6 Human RCT: OPTIMAL oral octreotide (Samson 2020) | Study | People / model | Route | Amount used | Follow-up | Reported | Side effects / limitations | Citation | |---|---|---|---|---|---|---|---| | Samson 2020 | 56 adults with controlled acromegaly | Oral | Not in abstract | 36 weeks | IGF-1 kept 58.2% vs 19.4% | Chiasma-run | [PMID 32882036](https://pubmed.ncbi.nlm.nih.gov/32882036/) · [NCT03252353](https://clinicaltrials.gov/study/NCT03252353) |

Full reference list (PubMed, ClinicalTrials.gov, openFDA and DailyMed entries checked Oct 25, 2026)

^R1 DailyMed. SANDOSTATIN (octreotide) injection label, Novartis, effective Jul 22, 2026. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4e2c9856-1836-49f0-9472-4dbeeb408f39
^R2 FDA. Drugs@FDA data (openFDA drugsfda), octreotide: NDA 019667, 021008, 208232, 213224 and generic ANDAs; checked Oct 25, 2026. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:octreotide
^R3 DailyMed. MYCAPSSA (octreotide) capsule label, Chiesi, effective Jul 24, 2025. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=58d80bc6-bdfb-4908-93e7-aace447c8d1a
^R4 Ezzat S, et al. Octreotide treatment of acromegaly. A randomized, multicenter study. Ann Intern Med. 1992. PMID 1416572
^R5 Rinke A, et al. 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. J Clin Oncol. 2009. PMID 19704057
^R6 Samson SL, et al. Maintenance of Acromegaly Control in Patients Switching From Injectable Somatostatin Receptor Ligands to Oral Octreotide. J Clin Endocrinol Metab. 2020. PMID 32882036
^R7 WADA. The 2026 Prohibited List (in force 1 January 2026). https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf

Disclaimer

This page is for education and harm reduction, not medical advice or a recommendation to use Octreotide. Talk to a clinician you trust before using any drug, and report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).

Approved for Adam Greene by Dr. Nova Reyes, 2026-10-25.