BLASUBCUTANEOUSINJECTABLEPriority Review
Approved
Mar 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
14
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SOMAVERT (pegvisomant) is a pegylated growth hormone receptor antagonist approved in 2003 for acromegaly, a rare endocrine disorder caused by excessive growth hormone secretion. It works by blocking growth hormone signaling at the receptor level, reducing insulin-like growth factor-1 (IGF-1) levels and clinical symptoms. This injectable biologic represents a targeted mechanism for patients who fail or are intolerant to somatostatin analogs and dopamine agonists.
$0.037BPart D
LOE ApproachingMature product with modest Medicare claims volume and approaching loss of exclusivity, signaling potential team contraction and shift toward managing decline.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (14)
Korean Regulatory Post Marketing Surveillance for Somavert
Started Jul 2022
11 enrolled
Acromegaly
Safety and Efficacy of Pegvisomant in Children With Growth Hormone Excess
Started Oct 2019
12 enrolled
Pituitary Disease
Pasireotide LAR and Pegvisomant Study in Acromegaly
Started Aug 2015
60 enrolled
Acromegaly
A Relative Bioavailability Study To Evaluate Safety, Tolerability And Pharmacokinetic Comparability Of Pegvisomant 1 X 30 Mg Vs 2 X 15 Mg Subcutaneously Administered In Healthy Subjects
Started Aug 2013
17 enrolled
Healthy Volunteers
Pegvisomant With Glucagon Test to Assess for Adult Growth Hormone Deficiency
Started Mar 2011
10 enrolled
Adults Growth Hormone Deficiency.
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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.