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.
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/04 | Phase 3 | Recruiting | |||
2024/09/23 | N/A | Completed | |||
2022/07/28 | Phase 3 | Recruiting | |||
2022/05/06 | Phase 1 | Terminated | |||
2021/09/21 | Phase 3 | Active, not recruiting | |||
2021/09/17 | Phase 1 | Recruiting | National Health Research Institutes, Taiwan | ||
2021/04/21 | Phase 3 | Completed | |||
2021/01/06 | N/A | Completed | |||
2020/06/11 | Phase 2 | UNKNOWN | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | ||
2019/08/22 | Phase 3 | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Cipla USA Inc. | 69097-890 | SUBCUTANEOUS | 90 mg in 0.3 mL | 9/1/2023 | |
| Ipsen Biopharmaceuticals, Inc. | 15054-1090 | SUBCUTANEOUS | 90 mg in 0.3 mL | 2/28/2023 | |
| Ipsen Biopharmaceuticals, Inc. | 15054-1060 | SUBCUTANEOUS | 60 mg in 0.2 mL | 2/28/2023 | |
| Cipla USA Inc. | 69097-870 | SUBCUTANEOUS | 120 mg in 0.5 mL | 9/1/2023 | |
| Ipsen Biopharmaceuticals, Inc. | 15054-1120 | SUBCUTANEOUS | 120 mg in 0.5 mL | 2/28/2023 | |
| Cipla USA Inc. | 69097-880 | SUBCUTANEOUS | 60 mg in 0.2 mL | 9/1/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Somatuline Autogel Prolonged Release Solution for Injection in a Pre-filled Syringe 90 mg | SIN14290P | INJECTION, SOLUTION | 90 mg | 1/16/2013 | |
| Somatuline Autogel Prolonged Release Solution for Injection in a Pre-filled Syringe 60 mg | SIN14291P | INJECTION, SOLUTION | 60 mg | 1/16/2013 | |
| Somatuline Autogel Prolonged Release Solution for Injection in a Pre-filled Syringe 120 mg | SIN14289P | INJECTION, SOLUTION | 120 mg | 1/16/2013 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| SOMATULINE AUTOGEL (lanreotide as acetate) 90mg solution for injection prefilled syringe | 95261 | Medicine | A | 9/11/2003 | |
| SOMATULINE AUTOGEL (lanreotide as acetate) 120mg solution for injection prefilled syringe | 95262 | Medicine | A | 9/11/2003 | |
| MYTOLAC lanreotide (as acetate) 120 mg solution for injection pre-filled syringe | 371879 | Medicine | A | 8/10/2022 | |
| SOMATULINE AUTOGEL (lanreotide as acetate) 60mg solution for injection prefilled syringe | 95260 | Medicine | A | 9/11/2003 | |
| MYTOLAC lanreotide (as acetate) 60 mg solution for injection pre-filled syringe | 371881 | Medicine | A | 8/10/2022 | |
| MYTOLAC lanreotide (as acetate) 90 mg solution for injection pre-filled syringe | 371880 | Medicine | A | 8/10/2022 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| SOMATULINA AUTOGEL 60 mg SOLUCION INYECTABLE EN JERINGA PRECARGADA | Ipsen Pharma S.A. | 64837 | SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA | Diagnóstico Hospitalario | Commercialized |
| SOMATULINA AUTOGEL 90 mg, SOLUCION INYECTABLE EN JERINGA PRECARGADA | Ipsen Pharma S.A. | 64838 | SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA | Diagnóstico Hospitalario | Commercialized |
| SOMATULINA AUTOGEL 120 mg SOLUCION INYECTABLE EN JERINGA PRECARGADA | Ipsen Pharma S.A. | 64839 | SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA | Diagnóstico Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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