LANREOTIDE ACETATE
LANREOTIDE ACETATE is indicated for the treatment of Acromegaly; Gastroenteropancreatic Neuroendocrine Tumors; Carcinoid Syndrome.
How LANREOTIDE ACETATE Works
Lanreotide is an octapeptide analog of natural somatostatin. It acts as a somatostatin receptor agonist, with high affinity for human somatostatin receptors 2 and 5 (SSTR2 and SSTR5). By binding to these receptors, it inhibits the secretion of various hormones, including growth hormone (GH) and insulin-like growth factor-1 (IGF-1), and exerts anti-proliferative effects on neuroendocrine tumor cells.
Details
- Status
- Prescription
- First Approved
- 2021-12-17
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
LANREOTIDE ACETATE Approval History
What LANREOTIDE ACETATE Treats
3 indicationsLANREOTIDE ACETATE is approved for 3 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acromegaly
- Gastroenteropancreatic Neuroendocrine Tumors
- Carcinoid Syndrome
LANREOTIDE ACETATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to LANREOTIDE ACETATE
3 of 11FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02075606 CALM-NET results posted | A-97-52030-270 2013-002194-22 | Ph 4 | completed | Circulating Tumour Cells in Somatuline Autogel Treated NeuroEndocrine Tumours Patients |
| NCT02493517 LANTERN results posted | 8-55-52030-289 CTR20140698 | Ph 3 | completed | Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg Prolonged Release (PR) in Acromegaly |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LANREOTIDE ACETATE FDA Label Details
Indications & Usage
FDA Label (PDF)LANREOTIDE ACETATE is indicated for the treatment of Acromegaly; Gastroenteropancreatic Neuroendocrine Tumors; Carcinoid Syndrome.
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SOMATULINE DEPOT
Full clinical data, patents, trials, and competitive landscape for lanreotide acetate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.