OCTREOTIDE ACETATE (PRESERVATIVE FREE) (octreotide acetate)
Octreotide Acetate helps patients with acromegaly by lowering blood levels of growth hormone and insulin growth factor-1 when surgery, radiation, or other medications have not worked. It also treats the severe flushing and diarrhea associated with metastatic carcinoid tumors. Additionally, the medication is used for patients with VIP-secreting tumors to manage profuse watery diarrhea.
How OCTREOTIDE ACETATE (PRESERVATIVE FREE) Works
This medication works by mimicking the actions of somatostatin, a natural hormone that inhibits the release of growth hormone, insulin, and glucagon. It also suppresses various other substances, such as serotonin and vasoactive intestinal peptide, while decreasing blood flow to internal organs. These actions help control the hormonal imbalances and gastrointestinal symptoms caused by certain tumors.
Details
- Status
- Prescription
- First Approved
- 2005-03-28
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
OCTREOTIDE ACETATE (PRESERVATIVE FREE) Approval History
What OCTREOTIDE ACETATE (PRESERVATIVE FREE) Treats
5 indicationsOCTREOTIDE ACETATE (PRESERVATIVE FREE) is approved for 5 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acromegaly
- Carcinoid Tumor
- Diarrhea
- Flushing
- Vasoactive Intestinal Peptide Tumor
OCTREOTIDE ACETATE (PRESERVATIVE FREE) 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
9 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 |
| 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.
OCTREOTIDE ACETATE (PRESERVATIVE FREE) FDA Label Details
Indications & Usage
OCTREOTIDE ACETATE (PRESERVATIVE FREE) is indicated for the treatment of Acromegaly; Carcinoid Tumor; Diarrhea; Flushing; Vasoactive Intestinal Peptide Tumor.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.