NDAORALCAPSULE, DELAYED RELEASE
Approved
Jun 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
MYCAPSSA (octreotide) by Chiesi is somatostatin receptor agonists [moa]. Approved for somatostatin analog [epc]. First approved in 2020.
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MYCAPSSA is an oral delayed-release capsule formulation of octreotide, a somatostatin receptor agonist that suppresses excessive hormone secretion. It is indicated for acromegaly and neuroendocrine tumors (carcinoid syndrome, vasoactive intestinal peptide tumors). The drug works by binding somatostatin receptors to inhibit growth hormone, insulin-like growth factor-1, and other pathologic hormone release.
$0.005BPart D
Peak14.6 years to LOEProduct is in peak commercial phase with limited Part D penetration (~567 claims in 2023), suggesting significant untapped market opportunity for field team expansion.
Mechanism of Action
Somatostatin Receptor Agonists
Pharmacologic Class:
Somatostatin Analog
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Preventing Postoperative Complications in Patients Undergoing High-risk Pancreatoduodenectomy With a Bundle Approach Including Hydrocortisone, Octreotide, and the Teres Ligament Patch (PANENCA)
Started Sep 2025
400 enrolled
Pancreas Head CancerPancreas AdenocarcinomaIPMN, Pancreatic+7 more
A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLD
Started Jun 2022
71 enrolled
Polycystic Liver Disease
A Feasibility Study of Octreotide Infusion During Liver Transplant.
Started May 2022
30 enrolled
Liver TransplantationRenal Failure
A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET
Started Oct 2021
332 enrolled
Gastro-enteropancreatic Neuroendocrine Tumor
Bioequivalence Study of Two Octreotide Microsphere Formulations in Healthy Volunteers
Started Jun 2021
240 enrolled
Healthy Volunteers
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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.