NDASUBCUTANEOUSSOLUTION
Approved
Sep 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
10
Data completeness
5/8 — Partial
BYNFEZIA PEN (octreotide acetate) by Fosun Pharma is (octreotide acetate) exerts pharmacologic actions similar to the natural hormone, somatostatin. First approved in 2024.
Drug data last refreshed 4h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BYNFEZIA PEN is a subcutaneous solution formulation of octreotide acetate, a somatostatin analog that potently inhibits growth hormone, glucagon, and insulin secretion. It is indicated for managing symptoms associated with metastatic carcinoid tumors (flushing and diarrhea) and VIP-secreting adenomas (watery diarrhea). The drug works by mimicking somatostatin's inhibitory effects on multiple hormones and neuroendocrine pathways.
Growth15.3 years to LOE
Recent 2024 approval positions BYNFEZIA PEN in growth phase with opportunity to build market share; commercial team will focus on market development and physician education in a niche specialty setting.
Mechanism of Action
(octreotide acetate) exerts pharmacologic actions similar to the natural hormone, somatostatin. It is an even more potent inhibitor of GH, glucagon, and insulin than somatostatin. Like somatostatin, it also suppresses luteinizing hormone (LH) response to gonadotropin releasing hormone (GnRH),…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (10)
Phase 1, Open-label, Drug-drug Interaction Study With Octreotide Acetate Injection and Telotristat Etiprate in Healthy Subjects
Started Jul 2014
24 enrolled
Drug Interactions
Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly
Started Mar 2006
20 enrolled
Acromegaly
Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly
Started Dec 2005
28 enrolled
Acromegaly
Extension Study of the Long-term Safety and Tolerability of Octreotide Acetate in Patients With Moderately Severe or Severe Non-proliferative Diabetic Retinopathy or Low Risk Proliferative Diabetic Retinopathy
Started Nov 2005
105 enrolled
Diabetic Retinopathy
Extension Study of Long-term Safety and Tolerability of Octreotide Acetate in Patients With Moderately Severe or Severe Non-proliferative Diabetic Retinopathy or Low Risk Proliferative Diabetic Retinopathy
Started Nov 2005
260 enrolled
Diabetic Retinopathy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.