MedPath

Lanreotide

Generic Name
Lanreotide
Brand Names
Somatuline
Drug Type
Small Molecule
Chemical Formula
C54H69N11O10S2
CAS Number
108736-35-2
Unique Ingredient Identifier
0G3DE8943Y

Overview

Lanreotide is a drug employed in the management of acromegaly (a hormonal condition caused by excess growth hormone) in addition to symptoms caused by neuroendocrine tumors, especially carcinoid syndrome. This drug is a long-acting analog of the drug somatostatin, a growth hormone inhibitor. Lanreotide is manufactured by the company, Ipsen Pharmaceuticals as lanreotide acetate, and marketed as Somatuline. It is approved in several countries worldwide, including the United Kingdom, Australia, and Canada. Lanreotide was first approved for use in the United States by the FDA on August 30, 2007.

Background

Lanreotide is a drug employed in the management of acromegaly (a hormonal condition caused by excess growth hormone) in addition to symptoms caused by neuroendocrine tumors, especially carcinoid syndrome. This drug is a long-acting analog of the drug somatostatin, a growth hormone inhibitor. Lanreotide is manufactured by the company, Ipsen Pharmaceuticals as lanreotide acetate, and marketed as Somatuline. It is approved in several countries worldwide, including the United Kingdom, Australia, and Canada. Lanreotide was first approved for use in the United States by the FDA on August 30, 2007.

Indication

Lanreotide is indicated for the long-term treatment of patients with acromegaly who have had an inadequate response to, or cannot be treated with, surgery and/or radiotherapy. It is also indicated in the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. Lanreotide is additionally indicated for the treatment of adults with carcinoid syndrome - when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.

Associated Conditions

  • Acromegaly
  • Carcinoid Syndrome
  • Unresectable, locally advanced enteropancreatic neuroendocrine tumors
  • Unresectable, locally advanced well- or moderately-differentiated Gastroenteropancreatic Neuroendocrine Tumors
  • Unresectable, metastatic enteropancreatic neuroendocrine tumors
  • Unresectable, metastatic well- or moderately-differentiated Gastroenteropancreatic Neuroendocrine Tumors

FDA Approved Products

SOMATULINE DEPOT
Manufacturer:Ipsen Biopharmaceuticals, Inc.
Route:SUBCUTANEOUS
Strength:60 mg in 0.2 mL
Approved: 2023/02/28
NDC:15054-1060
Lanreotide Acetate
Manufacturer:Cipla USA Inc.
Route:SUBCUTANEOUS
Strength:90 mg in 0.3 mL
Approved: 2023/09/01
NDC:69097-890
Lanreotide Acetate
Manufacturer:Cipla USA Inc.
Route:SUBCUTANEOUS
Strength:60 mg in 0.2 mL
Approved: 2023/09/01
NDC:69097-880
SOMATULINE DEPOT
Manufacturer:Ipsen Biopharmaceuticals, Inc.
Route:SUBCUTANEOUS
Strength:90 mg in 0.3 mL
Approved: 2023/02/28
NDC:15054-1090
SOMATULINE DEPOT
Manufacturer:Ipsen Biopharmaceuticals, Inc.
Route:SUBCUTANEOUS
Strength:120 mg in 0.5 mL
Approved: 2023/02/28
NDC:15054-1120

Singapore Approved Products

Somatuline Autogel Prolonged Release Solution for Injection in a Pre-filled Syringe 90 mg
Manufacturer:IPSEN PHARMA BIOTECH, IPSEN PHARMA BIOTECH, ETABLISSEMENT GAMMASTER - Gamma Irradiation, STERIGENICS BELGIUM - Gamma Irradiation
Form:INJECTION, SOLUTION
Strength:90 mg
Online:Yes
Approved: 2013/01/16
Approval:SIN14290P
Somatuline Autogel Prolonged Release Solution for Injection in a Pre-filled Syringe 60 mg
Manufacturer:Ipsen Pharma Biotech, IPSEN PHARMA BIOTECH, ETABLISSEMENT GAMMASTER - Gamma Irradiation, STERIGENICS BELGIUM - Gamma Irradiation
Form:INJECTION, SOLUTION
Strength:60 mg
Online:Yes
Approved: 2013/01/16
Approval:SIN14291P
Somatuline Autogel Prolonged Release Solution for Injection in a Pre-filled Syringe 120 mg
Manufacturer:IPSEN PHARMA BIOTECH, IPSEN PHARMA BIOTECH, ETABLISSEMENT GAMMASTER - Gamma Irradiation, STERIGENICS BELGIUM - Gamma Irradiation
Form:INJECTION, SOLUTION
Strength:120 mg
Online:Yes
Approved: 2013/01/16
Approval:SIN14289P

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