Osilodrostat clinical trials
Osilodrostat is named as an intervention in 4 current clinical trials in our USA, France, Italy, UK, Belgium, Germany, Netherlands and Switzerland registers. 2 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is RECORDATI GROUP (3). The most-studied condition is Cushing Syndrome. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Osilodrostat is approved
All regulators →Of the three regulators tracked here, the first to approve Osilodrostat was the EU, on 9 Jan 2020. It is approved in 3 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for treatment of Cushing's syndrome (15 Oct 2014, positive)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Osilodrostat patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Osilodrostat, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 5 listed patents; the last listed expires 12 Oct 2035 (US 10709691).
- Latest patent on the drug substance itself: 20 May 2033 (US 8314097).
- Exclusivity ODE-535: Orphan drug exclusivity: treatment of endogenous hypercortisolemia in adults with cushing's syndrome for whom surgery is not an option or h…, until 15 Apr 2032.
- Exclusivity ODE-286: Orphan drug exclusivity: indicated for the treatment of adult patients with cushing’s disease for whom pituitary surgery is not an option o…, until 6 Mar 2027.
- Isturisa for treatment of Cushing's syndrome: until 13 Jan 2030. Union Register
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Osilodrostat
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Osilodrostat works
All drug targets →- Cytochrome P450 11B1 inhibitor InhibitorTarget: CYP11B1 cytochrome P450 family 11 subfamily B member 1✓ In ChEMBL and the Guide to Pharmacology
- ACTH-dependent Cushing syndromePhase 3
- Hypertension resistant to conventional therapyPhase 2
- Essential hypertensionPhase 2
- Hypertensive disorderPhase 2
- Primary aldosteronismPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3099695, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 8310, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Osilodrostat
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 3 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: IsturisaEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Osilodrostat
- ChEMBL
- CHEMBL3099695
- DrugBank
- DB11837
- PubChem CID
- 44139752
- CAS number
- 928134-65-0
- FDA UNII
- 5YL4IQ1078
- Wikidata
- Q27088216
- Wikipedia
- Osilodrostat
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Osilodrostat
4 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Osilodrostat in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Osilodrostat. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
A double-blind, randomised, 30-week placebo-controlled phase IV study to assess the efficacy and safety of osilodrostat in patients with hypertension caused by hypercortisolaemia due to Cushing’s Syndrome
2025-524649-28-00 · Hormonal diseases
|
Phase 4 | Ongoing | Recordati AG | Germany, Bulgaria, France + 4 more |
Osilodrostat across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
3 single-substance products containing Osilodrostat on the HPRA medicines list.
- Isturisa 1 mg film-coated tabletsRecordati Rare Diseases · EU/1/19/1407/001
- Isturisa 10 mg film-coated tabletsRecordati Rare Diseases · EU/1/19/1407/003
- Isturisa 5 mg film-coated tabletsRecordati Rare Diseases · EU/1/19/1407/002
Supply shortages
No entry for Osilodrostat in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Osilodrostat
6 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| RECORDATI GROUP | 3 |
| Beckey Trinh | 1 |
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Osilodrostat trials
How many clinical trials are testing Osilodrostat?
4 current trials in our USA, France, Italy, UK, Belgium, Germany, Netherlands and Switzerland registers name Osilodrostat (also registered as LCI699) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Osilodrostat trials recruiting patients?
Yes. 2 of the 4 trials are recruiting: 2 with sites in USA, 1 with sites in France, 1 with sites in Italy, 1 with sites in UK and 1 with sites in Belgium. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Osilodrostat clinical trials?
RECORDATI GROUP (3) and Beckey Trinh (1). The number in brackets is how many trials each organisation leads.
Is Osilodrostat licensed in Ireland?
Yes. The HPRA medicines list includes 3 single-substance products containing Osilodrostat, for example Isturisa 1 mg film-coated tablets (Recordati Rare Diseases). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Osilodrostat shortage?
Not in the lists we track: Osilodrostat has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Osilodrostat works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Osilodrostat works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Osilodrostat (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.