OCTREOTIDE ACETATE · Viatris
Octreotide acetate is indicated to reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1) in patients with acromegaly who have had an inadequate response to, or are not candidates for, surgical resection, pituitary irradiation, or maximally tolerated doses of bromocriptine mesylate. It is also indicated for the
How OCTREOTIDE ACETATE Works
This medication works by mimicking the actions of the natural hormone somatostatin to inhibit the release of growth hormone, insulin, and glucagon. It also suppresses various other hormones and proteins, such as serotonin and gastrin, while decreasing blood flow to the internal organs. These combined effects help manage the symptoms caused by hormone-secreting tumors.
Details
- Status
- Prescription
- First Approved
- 1988-10-21
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
Companies
OCTREOTIDE ACETATE Approval History
What OCTREOTIDE ACETATE Treats
3 indicationsOCTREOTIDE ACETATE is approved for 3 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acromegaly
- Metastatic carcinoid tumors
- Vasoactive intestinal peptide tumors (VIPomas)
OCTREOTIDE 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.
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Viatris's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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| NCT06126354 | AAAU7680 3P30DK063608 | Ph 1 | withdrawn | Dexamethasone/Pancreatic Clamp P&F |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 FDA Label Details
Indications & Usage
Octreotide Acetate Injection is a somatostatin analogue indicated: Acromegaly : To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. Carcinoid Tumors : For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. Vasoactive Intestinal Peptide Tumors (VIP...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.