SOMATULINE DEPOT (lanreotide acetate)
SOMATULINE DEPOT is indicated for the treatment of Acromegaly; Gastroenteropancreatic Neuroendocrine Tumors; Carcinoid Syndrome.
How SOMATULINE DEPOT Works
Lanreotide is an octapeptide analog of natural somatostatin. It is believed to function similarly to endogenous somatostatin by binding to somatostatin receptors to inhibit the secretion of various hormones. In patients with acromegaly, this action suppresses the secretion of growth hormone (GH), subsequently lowering insulin growth factor-1 (IGF-1) levels toward a normal range.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2007-08-30
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
SOMATULINE DEPOT Approval History
What SOMATULINE DEPOT Treats
3 indicationsSOMATULINE DEPOT is approved for 3 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acromegaly
- Gastroenteropancreatic Neuroendocrine Tumors
- Carcinoid Syndrome
SOMATULINE DEPOT 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.
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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.
SOMATULINE DEPOT FDA Label Details
Indications & Usage
FDA Label (PDF)SOMATULINE DEPOT is indicated for the treatment of Acromegaly; Gastroenteropancreatic Neuroendocrine Tumors; Carcinoid Syndrome.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment