NDAORALTABLET
Approved
Mar 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
11
Data completeness
6/8 — Strong
ISTURISA (osilodrostat) by Recordati is inhibitor. First approved in 2020.
Drug data last refreshed 17h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ISTURISA (osilodrostat) is an oral small-molecule inhibitor of 11beta-hydroxylase (CYP11B1) that blocks the final step of cortisol biosynthesis in the adrenal gland. It is indicated for patients with Cushing's syndrome who require cortisol reduction. The drug demonstrates potent enzyme inhibition with IC50 values of 2.5 nM in human CYP11B1 overexpression systems.
$0.035BPart D
Peak9.1 years to LOEProduct is in peak lifecycle with modest Part D spending of $35M (2023), suggesting a niche rare-disease franchise with stable but limited sales trajectory.
Mechanism of Action
inhibitor. It inhibits 11beta-hydroxylase (CYP11B1), the enzyme responsible for the final step of cortisol biosynthesis in the adrenal gland. In a Chinese hamster lung cell line V79-4 that overexpresses human CYP11B1, adrenodoxin and adrenodoxin reductase, osilodrostat inhibited the activity of…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (11)
Osilodrostat in Patients With Hypertension Caused by Hypercortisolaemia Due to Cushing's Syndrome
Started Aug 2026
63 enrolled
HypertensionHypercortisolemiaCushing Syndrome
Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
Started Feb 2026
10 enrolled
Mild Autonomous Cortisol Secretion (MACS)
Impact of 1 mg Osilodrostat Therapy on Mild Autonomous Cortisol Secretion (MACS)
Started Jan 2026
15 enrolled
Mild Autonomous Cortisol SecretionAutonomous Cortisol Secretion (ACS)
A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement
Started Jul 2024
12 enrolled
Endogenous Cushing SyndromeAdrenal InsufficiencyHypercortisolism
Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's Syndrome
Started Jan 2023
103 enrolled
Cushing's Syndrome
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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.