SANDOSTATIN (octreotide acetate) · Novartis
SANDOSTATIN is FDA-approved to treat 5 conditions (same as OCTREOTIDE ACETATE (PRESERVATIVE FREE)).
Development Insights
Details
- Status
- Discontinued
- First Approved
- 1988-10-21
- Revenue
- $302M (Q2-2026)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
SANDOSTATIN Approval History
What SANDOSTATIN Treats
5 indicationsSANDOSTATIN is approved for 5 conditions since its original approval in 1988. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acromegaly
- Carcinoid Tumor
- Diarrhea
- Flushing
- Vasoactive Intestinal Peptide Tumor
Same approved indications as OCTREOTIDE ACETATE (PRESERVATIVE FREE) (same active ingredient).
Novartis's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03879694 | I 79518 NCI-2019-00827, I 79518 | Ph 1 | completed | Survivin Long Peptide Vaccine in Treating Patients With Metastatic Neuroendocrine Tumors |
| NCT06558422 | AAAU9702 P30DK063608, K12DK133995 | Ph 1 | not yet recruiting | Human Models of Selective Insulin Resistance: Pancreatic Clamp |
| NCT05724134 | AAAU3014 3P30DK063608 | Ph 1 | completed | Pancreatic Clamp in NAFLD |
| NCT06126354 | AAAU7680 3P30DK063608 | Ph 1 | withdrawn | Dexamethasone/Pancreatic Clamp P&F |
| NCT01229943 results posted | NCI-2011-02609 NCI-2011-02609, CDR0000687459 | Ph 2 | completed | Everolimus and Octreotide Acetate With or Without Bevacizumab in Treating Patients With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors That Cannot Be Removed by Surgery |
| NCT04129255 CSMS99 | IMMUNeOCT | Ph 2 | completed | Octreotide LAR in the Induction of Immunologic Response in NENs Patients |
| NCT04140409 SCIROCCO | SCIROCCO | Ph 4 | terminated | Sandostatin (Octreotide LAR) May Lead to Clinical Improvement Through Receptor Occupation Optimisation |
| NCT02195635 | LX1606.1-109-NRM LX1606.109 | Ph 1 | completed | Phase 1, Open-label, Drug-drug Interaction Study With Octreotide Acetate Injection and Telotristat Etiprate in Healthy Subjects |
| NCT01204476 | NCI-2010-02196 NCI-2010-02196, CDR0000685267 | Ph 1 | completed | Cixutumumab, Everolimus, and Octreotide Acetate in Treating Patients With Advanced Low to Intermediate Grade Neuroendocrine Carcinoma |
| NCT01469338 | 4P-11-3 NCI-2011-03266 | Ph 2 | terminated | Cabazitaxel Plus Prednisone With Octreotide For Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel |
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.
SANDOSTATIN FDA Label Details
Indications & Usage
FDA Label (PDF)SANDOSTATIN is FDA-approved to treat 5 conditions — same approved indications as OCTREOTIDE ACETATE (PRESERVATIVE FREE).
Pro Intelligence Preview
Deep insights for SANDOSTATIN
Revenue Insights
- • Q2-2026: $302M
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • 10 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
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