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Evidence: HighPeptideIn Clinical TrialsSomatostatin analogueNot FDA-approvedVariceal bleeding

Vapreotide

A somatostatin analogue for bleeding varices that never reached US approval

Vapreotide is a somatostatin analogue developed at Tulane University and licensed to Debiopharm. In a phase 3 trial in patients with cirrhosis and bleeding oesophageal varices, starting it early, before endoscopy, improved control of bleeding and survival over five days. It has no FDA approval.

Overview

What is it?

Bleeding from oesophageal varices is a life-threatening complication of portal hypertension in cirrhosis, and recommended treatment includes giving a vasoactive drug early. Vapreotide is a somatostatin analogue with a different receptor affinity from octreotide; in rats with cirrhosis it lowered portal pressure and blood flow in collateral vessels, and it is much more metabolically stable than somatostatin itself.

Its pivotal trial gave vapreotide or placebo a mean of 2.3 hours after admission, before endoscopic treatment. At endoscopy, active bleeding was seen in 31% on vapreotide against 46% on placebo, and survival with control of bleeding over five days was 66% against 50%. Reviews also describe a meta-analysis of four randomised studies showing better bleeding control, and a mortality reduction in the subset with significant bleeding.

It was also explored for prostate cancer and acromegaly, and sustained-release forms were developed. Despite the variceal results, an openFDA search finds no US approval.

Structured data

At a Glance

Every value in this table is printed from the Grey Peptides dataset, the same record the compound explorer and comparison tool read, so the three can never disagree.

ClassA somatostatin analogue with a receptor affinity different from octreotide's, developed for acute variceal bleeding in cirrhosis; a phase 3 trial improved bleeding control and survival, but it has no FDA approval.
US statusIn Clinical Trials
Evidence levelHigh
Last reviewed2026-10-03
Evidence

Published Research

Studies of vapreotide, from their PubMed abstracts.

Human2001

Early vapreotide for variceal bleeding

In 196 patients with cirrhosis, active bleeding at endoscopy was 31% on vapreotide against 46% on placebo (P = 0.03), and survival with bleeding control over 5 days was 66% against 50% (P = 0.02).

PMID: 11136956
Review2008

The evidence base

Vapreotide, with a receptor affinity different from octreotide's, lowered portal pressure in cirrhotic rats; its pivotal trial improved bleeding control, with lower mortality in significant bleeding, and a meta-analysis of four trials improved bleeding control.

PMID: 19072353
Review2009

Benefit and side effects

Vapreotide appeared to help control acute variceal bleeding, was easy to give and had few, minor side effects; the authors called for further trials.

PMID: 19708854
Review2003

Drug profile

Vapreotide (Octastatin, Sanvar, RC 160, BMY 41606), developed at Tulane University and licensed to Debiopharm, is far more metabolically stable than somatostatin and is usually given subcutaneously, with slow-release forms in development.

PMID: 12952505
Review2000

Development programme

Debiopharm was running phase 3 trials of vapreotide in prostate cancer in France and in acute oesophageal variceal bleeding in France and Asia, and investigating acromegaly.

PMID: 16047258
Safety

Side Effects & Contraindications

Reported Side Effects

From the studies above.

● Few side effects, usually minor

Contraindications & Cautions

No US label; it is not approved in the US.

● Not approved by FDA
Questions

Frequently Asked Questions

?What is vapreotide?

A somatostatin analogue, related to octreotide, developed mainly for acute bleeding from oesophageal varices in cirrhosis.

?Did it work?

In its pivotal trial, survival with control of bleeding over five days was 66% on vapreotide against 50% on placebo when started before endoscopy.

?Is vapreotide approved in the US?

No. An openFDA search of Drugs@FDA finds no approval.

?How is it different from octreotide?

Reviews describe it as having a different somatostatin receptor affinity from octreotide; both lower portal pressure, and octreotide is approved in the US for other uses.

?How was it given in the bleeding trial?

As an intravenous bolus followed by an infusion of 50 micrograms per hour for five days, started a mean of 2.3 hours after admission, with endoscopic treatment a mean of 2.6 hours after the infusion began.

?Was it tested for other conditions?

Yes. Debiopharm ran phase 3 trials in prostate cancer in France and investigated acromegaly, and slow-release intramuscular and other sustained-release forms were developed.

?Can I buy vapreotide?

It has no FDA approval, so anything sold under its name in the US is an unverified research chemical rather than a licensed medicine.

Bibliography

References

  1. [fda] US FDA, Drugs@FDA via openFDA: search for generic name vapreotide returned no records. Read October 3, 2026.
  2. [clinical-trial] Calès P, et al. "Early administration of vapreotide for variceal bleeding in patients with cirrhosis." N Engl J Med, 2001;344(1):23-8. PMID: 11136956.
  3. [pubmed] Calès P. "Vapreotide acetate for the treatment of esophageal variceal bleeding." Expert Rev Gastroenterol Hepatol, 2008;2(2):185-92. PMID: 19072353.
  4. [pubmed] Fortune BE, et al. "Vapreotide: a somatostatin analog for the treatment of acute variceal bleeding." Expert Opin Pharmacother, 2009;10(14):2337-42. PMID: 19708854.
  5. [pubmed] "Vapreotide: BMY 41606, RC 160, Sanvar." Drugs R D, 2003;4(5):326-30. PMID: 12952505.
  6. [pubmed] Norman P. "Vapreotide (Debipharm)." IDrugs, 2000;3(11):1358-72. PMID: 16047258.

Sources & Citations

Studies were read from their PubMed records; the FDA check is listed below, read October 3, 2026.

Medical Disclaimer: This content is for educational and informational purposes only. It is not medical advice, and nothing here is an instruction to obtain or use any compound. Consult a licensed healthcare provider before making health decisions.

Last reviewed: 2026-10-03