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Isturisa (OSILODROSTAT)
Isturisa blocks the production of cortisol in the adrenal glands by inhibiting the cytochrome P450 11B2 enzyme.
Isturisa (osilodrostat) is a cortisol synthesis inhibitor developed by Recordati Rare, targeting the cytochrome P450 11B2 enzyme in the mitochondria. It is a small molecule modality approved by the FDA in 2020 for the treatment of hypercortisolism and pituitary-dependent Cushing's disease. Isturisa is a patented medication with no generic manufacturers available. Key safety considerations include the potential for adrenal insufficiency and other endocrine-related adverse effects. As a cortisol synthesis inhibitor, Isturisa works by blocking the production of cortisol in the adrenal glands.
At a glance
| Generic name | OSILODROSTAT |
|---|---|
| Sponsor | Recordati |
| Drug class | Cortisol Synthesis Inhibitor |
| Target | Cytochrome P450 11B2, mitochondrial |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | FDA-approved |
| First approval | 2020 |
| Annual revenue | 200 |
Mechanism of action
Osilodrostat is cortisol synthesis inhibitor. It inhibits 11beta-hydroxylase (CYP11B1), the enzyme responsible for the final step of cortisol biosynthesis in the adrenal gland. In Chinese hamster lung cell line V79-4 that overexpresses human CYP11B1, adrenodoxin and adrenodoxin reductase, osilodrostat inhibited the activity of human CYP11B1 dose-dependently with IC50 values of 2.5 +- 0.1 nM (n 4).
Approved indications
- Hypercortisolism
- Pituitary-dependent Cushing's disease
Common side effects
- Adrenal insufficiency
- Fatigue
- Nausea
- Headache
- Edema
- Nasopharyngitis
- Vomiting
- Arthralgia
- Back pain
- Rash
- Diarrhea
- Blood corticotrophin increased
Key clinical trials
- Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Syndrome (PHASE2)
- Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS) (PHASE4)
- Impact of 1 mg Osilodrostat Therapy on Mild Autonomous Cortisol Secretion (MACS) (PHASE2)
- Osilodrostat in Patients With Hypertension Caused by Hypercortisolaemia Due to Cushing's Syndrome (PHASE4)
- Metyrapone Versus Osilodrostat in Patients With Metabolic Autonomous Cortisol Secretion (MACS) (PHASE4)
- Non-interventional Study on Osilodrostat in Patients With Endogenous Cushing's Syndrome
- A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement
- Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's Syndrome
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Isturisa CI brief — competitive landscape report
- Isturisa updates RSS · CI watch RSS
- Recordati portfolio CI