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 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MYCAPSSA is an oral delayed-release capsule formulation of octreotide, a somatostatin receptor agonist that mimics the hormone somatostatin to suppress hormone secretion. It is used to treat acromegaly and carcinoid syndrome by binding somatostatin receptors and inhibiting growth hormone and other pathological hormone production. This represents the first oral octreotide option, shifting treatment from injectable formulations.
$5.0MPart D
Peak14.5 years to LOEProduct is in peak lifecycle phase with modest spending (~$5M annually), suggesting a small but established commercial team focused on maintenance and market penetration in orphan/specialty indication segments.
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)
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Started Jun 2026
200 enrolled
Acromegaly
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
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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.