Drugs / osilodrostat
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Cushing syndrome 2 milestones | |||||
| Filed | Japan (PMDA) | — | Cushing syndrome | 2020-03-26 | “Recordati announces the submission of the Japanese New Drug Application (JNDA) to the Ministry of Health, Labour and Welfare seeking marketing approval for osilodrostat” recordati.com ↗ |
| Filed | US (FDA) | Isturisa | Cushing syndrome | — | “Recordati submitted the supplemental New Drug Application (sNDA) for the label extension of osilodrostat (Isturisa ®) for Cushing’s syndrome in June 2024” recordati.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (2) | US (FDA) | ISTURISA | — | 2025-04-15 – 2025-07-03 | fda.gov ↗ |
| Approved | US (FDA) | ISTURISA | — | 2020-03-06 | fda.gov ↗ |
| Approved | EU (EMA) | Isturisa | — | 2020-01-09 | europa.eu ↗ |
Trials 17
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02399202 | Nov 2015 → Mar 2016 | impaired renal function disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02372084 | Apr 2015 → May 2016 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT07104812 | Jan 2026 → Jan 2027 expected | adrenal gland disorder | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT03708900 | Apr 2021 → Jul 2027 expected | Cushing syndrome | RECORDATI GROUP | Recruiting | No outcome recorded |
| Phase 2 | NCT03606408 | Oct 2018 → Nov 2023 | endogenous Cushing syndrome | RECORDATI GROUP | Completed | No outcome recorded |
| Phase 2 | NCT02468193 | Sep 2015 → Jun 2018 | Cushing syndrome, adrenal carcinoma, benign neoplasm of adrenal gland, ectopic ACTH secretion syndrome +1 | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01331239 | Mar 2011 → Oct 2019 | Cushing disease due to pituitary adenoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00817414 | Jan → Aug 2009 | hypertensive disorder | Novartis | Completed | No outcome recorded |
| Phase 2 | NCT00817635 | Dec 2008 → Oct 2009 | hypertensive disorder | Novartis | Completed | No outcome recorded |
| Phase 2 | NCT00758524 | Sep 2008 → Jul 2009 | essential hypertension | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00732771 | Jun 2008 → May 2009 | primary aldosteronism | Novartis | Completed | No outcome recorded |
| Phase 32 trials · 2 met primary | ||||||
| Phase 3 | NCT02697734 | Oct 2016 → Jun 2019 | Cushing syndrome | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02180217 | Oct 2014 → Feb 2018 | Cushing disease due to pituitary adenoma | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT07247162 | Aug 2026 → May 2028 expected | Cushing syndrome, adrenal gland hyperfunction, hypertensive disorder | RECORDATI GROUP | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07247058 | Feb 2026 → Dec 2028 expected | ACTH-independent Cushing syndrome | Johns Hopkins University | Recruiting | No outcome recorded |
| Phase 4 | NCT07268222 | Dec 2025 → Nov 2026 expected | ACTH-independent Cushing syndrome | Laiko General Hospital, Athens | Recruiting | No outcome recorded |
| Phase 4 | NCT06131580 | Oct 2023 → Nov 2025 | endogenous Cushing syndrome | University of Montreal Hospital Centre (CHUM) | Unknown | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT07603466 Comparator | May 2026 → Jun 2028 expected | ACTH-dependent Cushing syndrome | University of Basrah | Enrolling by invitation | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2025-04-16 | RECORDATI GROUP | Regulatory RECORDATI: FDA GRANTS ISTURISA® (OSILODROSTAT) EXPANDED INDICATION FOR THE TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN PATIENTS WITH CUSHING’S SYNDROME recordati.com ↗ |
| 2021-03-24 | RECORDATI GROUP | Regulatory RECORDATI: ISTURISA® (OSILODROSTAT) APPROVED IN JAPAN, recordati.com ↗
Recordati today announces the Japanese Ministry of Health, Labour and Welfare (MHLW) approval of Isturisa® (osilodrostat) for the treatment of patients with endogenous Cushing’s syndrome for whom pituitary surgery is not an option or has not been curative. |
| 2020-06-17 | RECORDATI GROUP | Results RECORDATI: ISTURISA® (OSILODROSTAT) PHASE III LINC-4 TRIAL MEETS ITS PRIMARY ENDPOINT IN CUSHING’S DISEASE, recordati.com ↗
Data from the LINC-4 study demonstrate that a significantly higher proportion of patients receiving Isturisa® achieve normal mUFC, the primary treatment goal for Cushing’s disease, after 12 weeks of treatment versus placebo (77% vs 8%; P<0.0001). |
| 2020-03-26 | RECORDATI GROUP | Regulatory RECORDATI SUBMITS NEW DRUG APPLICATION FOR ISTURISA® IN JAPAN, recordati.com ↗
Recordati announces the submission of the Japanese New Drug Application (JNDA) to the Ministry of Health, Labour and Welfare seeking marketing approval for osilodrostat an oral inhibitor of 11-beta-hydroxylase for the treatment of patients with Cushing ‘s syndrome (CS). |
| 2020-03-09 | RECORDATI GROUP | Regulatory RECORDATI: ISTURISA® (OSILODROSTAT) APPROVED IN THE U.S., recordati.com ↗
Recordati today announces the FDA approval of Isturisa® (osilodrostat) for the treatment of patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative. |
| 2020-01-15 | RECORDATI GROUP | Regulatory RECORDATI: ISTURISA® (OSILODROSTAT) APPROVED, recordati.com ↗
Recordati announces that the European Commission has granted marketing authorisation for the orphan medicinal product Isturisa® (osilodrostat), indicated for the treatment of endogenous Cushing’s syndrome (CS) in adults. |
| 2019-11-15 | RECORDATI GROUP | Regulatory RECORDATI: CHMP ADOPTS POSITIVE OPINION FOR ISTURISA® (OSILODROSTAT), recordati.com ↗ |
| 2013-02-12 | RECORDATI GROUP | Results Recordati: positive preliminary 2012 results. Sales +8.7%, EBIT +2.1%, net income +1.8%. A productive year for investments, recordati.com ↗
Results from LINC 4, the first Phase III study in patients with Cushing’s disease to include an upfront, double-blind, randomised, placebo-controlled period, demonstrated that Isturisa® provided rapid and sustained normalisation of mean urinary free cortisol (mUFC) levels. |
All press releases naming this drug 16 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | osilodrostat | “osilodrostat (LCI699) is in the form of tablets 1 milligram (mg), 5 mg, and 10mg or in form of capsules 0.1 mg, 0.2 mg, 0.5 mg, 1 mg or 5 mg, both the formulations for oral...” NCT03708900 ↗13“Osilodrostat 1 mg and 5 mg capsules, was prepared by Novartis and supplied to the Investigator.” NCT01331239 ↗ “Drug: osilodrostat” NCT06131580 ↗ |
| Known as | Isturisa | ChEMBL registry synonym — accepted as the source's own label CHEMBL3099695 ↗ |
| Known as | LCI-699-NX | ChEMBL registry synonym — accepted as the source's own label CHEMBL3099695 ↗ |
| Known as | LCI699 | “osilodrostat ( LCI699)” NCT02399202 ↗7“LCI699 (osilodrostat)” NCT07247162 ↗ |
| Known as | LCI699-AZA | ChEMBL registry synonym — accepted as the source's own label CHEMBL3099695 ↗ |
| Known as | OSILODROSTAT PHOSPHATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3099695 ↗ |
| Action | Inhibit | “effectively and safely inhibits aldosterone synthase in patients with primary aldosteronism” PMID 20837883 ↗ Sep 2010 |
| Modality | Small molecule | — CHEMBL3099695 ↗ |
| Route | Oral | “patients received oral LCI699 (0.5 mg BID) for 2 weeks” PMID 20837883 ↗ Sep 2010 |
| Target | CYP11B1 | “Osilodrostat (LCI699) is a new steroidogenesis inhibitor of 11β-hydroxylase (CYP11β1) that induced remission of hypercortisolism in 86% of patients with refractory CD in the...” PMID 33074401 ↗ Oct 2020 |