BYNFEZIA PEN (octreotide acetate)
Bynfezia Pen helps patients manage acromegaly by lowering blood levels of growth hormone and insulin growth factor-1 when surgery, radiation, or other medications are not effective or possible. It also treats the severe flushing and diarrhea associated with metastatic carcinoid tumors. Furthermore, the medication is used to control the profuse watery diarrhea caused by tumors that secrete vasoactive intestinal peptide (VIPomas).
How BYNFEZIA PEN Works
This medication works by mimicking the actions of the natural hormone somatostatin, though it is a more potent inhibitor of growth hormone, glucagon, and insulin. It suppresses the release of various substances in the body, including serotonin and vasoactive intestinal peptide, while also decreasing blood flow to internal organs. These actions help reduce the hormonal imbalances and gastrointestinal symptoms caused by certain types of tumors.
Details
- Status
- Prescription
- First Approved
- 2024-09-27
- Patent Cliff
- 2041
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
BYNFEZIA PEN Approval History
What BYNFEZIA PEN Treats
5 indicationsBYNFEZIA PEN is approved for 5 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acromegaly
- Carcinoid Tumor
- Diarrhea
- Flushing
- Vasoactive Intestinal Peptide Tumor
BYNFEZIA PEN 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 BYNFEZIA PEN
3 of 18FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
BYNFEZIA PEN FDA Label Details
Indications & Usage
FDA Label (PDF)BYNFEZIA PEN is indicated for the treatment of Acromegaly; Carcinoid Tumor; Diarrhea; Flushing; Vasoactive Intestinal Peptide Tumor.
BYNFEZIA PEN Patents & Exclusivity
Patents (5 active)
Pro Intelligence Preview
Deep insights for BYNFEZIA PEN
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 13 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 18 similar drugs
- • 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.