NDASUBCUTANEOUSSOLUTION
Approved
Sep 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
10
Data completeness
6/8 — Strong
BYNFEZIA PEN (octreotide acetate) by Fosun Pharma is (octreotide acetate) exerts pharmacologic actions similar to the natural hormone, somatostatin. Approved for acromegaly. First approved in 2024.
Drug data last refreshed 23h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BYNFEZIA PEN is a subcutaneous octreotide acetate solution approved by the FDA on September 27, 2024, for the treatment of acromegaly. Octreotide works as a potent somatostatin analog that inhibits growth hormone, glucagon, and insulin secretion while suppressing multiple neuroendocrine substances. The drug is particularly effective at controlling hormone levels and symptoms associated with GH-secreting tumors.
Growth15.7 years to LOE
Early-stage product in growth phase with 15.7 years of patent protection; expect expanding commercial infrastructure and team investment.
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 (1)
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 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
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
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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.