12 completed, 6 recruiting, 1 active not recruiting, 1 enrolling by invitation. 9 Phase 2, 4 Phase 4, 2 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 9 | Completed 7, Recruiting 2 |
| Phase 4 | 4 | Recruiting 3, Enrolling by invitation 1 |
| Phase 1 | 2 | Completed 2 |
| Phase 3 | 2 | Completed 2 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Osilodrostat in Patients With Hypertension Caused by Hypercortisolaemia Due to Cushing's Syndrome Osilodrostat, Placebo - Hypertension, Hypercortisolemia | Phase 4 | Recruiting | RECORDATI GROUP | 63 | 2026-08-26 | 2026-10-28 |
| Combination Osilodrostat and Cabergoline in Cushing's Disease osilodrostat, osilodrostat and cabergoline - Cushing Disease Due to Increased ACTH Secretion | Phase 4 | Enrolling by invitation | University of Basrah | 50 | 2026-05-11 | 2026-05-22 |
| Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS) Osilodrostat (Isturisa) - Mild Autonomous Cortisol Secretion (MACS) | Phase 4 | Recruiting | Johns Hopkins University | 10 | 2026-02-02 | 2026-10-23 |
| Impact of 1 mg Osilodrostat Therapy on Mild Autonomous Cortisol Secretion (MACS) Osilodrostat 1 MG - Mild Autonomous Cortisol Secretion, Autonomous Cortisol Secretion (ACS) | Phase 2 | Recruiting | Mayo Clinic | 15 | 2026-01-14 | 2026-02-11 |
| Metyrapone Versus Osilodrostat in Patients With Metabolic Autonomous Cortisol Secretion (MACS) Metyrapone 250 mg Oral Tablets, Osilodrostat 1 MG, adrenalectomy - Mild Autonomous Cortisol Secretion (MACS) | Phase 4 | Recruiting | Laikο General Hospital, Athens | 150 | 2025-12-01 | 2025-12-05 |
| A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement Osilodrostat - Endogenous Cushing Syndrome, Adrenal Insufficiency | Recruiting | University of Michigan | 12 | 2024-07-19 | 2026-09-09 | |
| Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's Syndrome Osilodrostat - Cushing's Syndrome | Completed | RECORDATI GROUP | 103 | 2023-01-16 | 2025-02-10 | |
| Non-interventional Study on Osilodrostat in Patients With Endogenous Cushing's Syndrome Osilodrostat - Endogenous Cushing's Syndrome | Active not recruiting | RECORDATI GROUP | 206 | 2022-06-13 | 2025-11-20 | |
| Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Syndrome LCI699 - Cushing Syndrome | Phase 2 | Recruiting | RECORDATI GROUP | 12 | 2021-04-28 | 2026-03-27 |
| Roll-over Study in Patients With Endogenous Cushing's Syndrome for LCI699 osilodrostat - Cushing's Syndrome | Phase 2 | Completed | RECORDATI GROUP | 127 | 2018-10-05 | 2024-12-18 |
| Efficacy and Safety Evaluation of Osilodrostat in Cushing's Disease osilodrostat, osilodrostat Placebo - Cushing's Disease | Phase 3 | Completed | Novartis Pharmaceuticals | 73 | 2016-10-03 | 2021-11-01 |
| A Phase I Study of Osilodrostat (LCI699) in Healthy Volunteers and Subjects With Impaired Renal Function osilodrostat - Renal Impairment | Phase 1 | Completed | Novartis Pharmaceuticals | 15 | 2015-11-06 | 2020-12-19 |
| Study of Efficacy and Safety of Osilodrostat in Cushing's Syndrome Osilodrostat - Cushing's Syndrome, Ectopic Corticotropin Syndrome | Phase 2 | Completed | Novartis Pharmaceuticals | 9 | 2015-09-24 | 2020-05-06 |
| A Phase 1 Study of Osilodrostat (LCI699) in Healthy Volunteers and Subjects With Impaired Hepatic Function osilodrostat - Hepatic Impairment | Phase 1 | Completed | Novartis Pharmaceuticals | 33 | 2015-04-21 | 2020-12-19 |
| Safety and Efficacy of LCI699 for the Treatment of Patients With Cushing's Disease osilodrostat, LCI699 matching placebo - Cushings Disease | Phase 3 | Completed | Novartis Pharmaceuticals | 137 | 2014-10-06 | 2021-01-06 |
| Safety and Efficacy of LCI699 in Cushing's Disease Patients LCI699 - Cushings Disease, Cushing Disease | Phase 2 | Completed | Novartis Pharmaceuticals | 31 | 2011-03-23 | 2021-01-22 |
| A Study to Evaluate the Effects of LCI699 on Cortisol in Participants With Hypertension LCI699-matching placebo, LCI699 - Hypertension | Phase 2 | Completed | Novartis | 63 | 2009-01-14 | 2021-06-02 |
| A Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo in Participants With Resistant Hypertension LCI699, Eplerenone, LCI699-matching Placebo - Hypertension | Phase 2 | Completed | Novartis | 155 | 2008-12-22 | 2021-06-02 |
| A Study to Evaluate Efficacy and Safety of LCI699 in Participants With Essential Hypertension LCI699, Eplerenone, LCI699-matching Placebo - Essential Hypertension | Phase 2 | Completed | Novartis Pharmaceuticals | 628 | 2008-09-11 | 2021-07-06 |
| Proof-of-concept for the Aldosterone Synthase Inhibitor LCI699 in Patients With Primary Hyperaldosteronism LCI699 - Primary Hyperaldosteronism | Phase 2 | Completed | Novartis | 12 | 2008-06-01 | 2009-08-26 |
Cushing Syndrome (8) · Hypertension (6) · ACTH Syndrome, Ectopic (4) · Pituitary ACTH Hypersecretion (3) · Pituitary Diseases (3) · Adrenal Hyperplasia, Congenital (2) · Adrenal Insufficiency (2) · Adrenocortical Hyperfunction (2) · Hypokalemia (2) · Acth-Independent Macronodular Adrenal Hyperplasia (1) · Adrenal Cortex Neoplasms (1) · Essential Hypertension (1) · Hyperaldosteronism (1) · Hyperandrogenism (1) · Renal Insufficiency (1)
Novartis Pharmaceuticals (7) · RECORDATI GROUP (5) · Novartis (3) · Johns Hopkins University (1) · Laikο General Hospital, Athens (1) · Mayo Clinic (1) · University of Basrah (1) · University of Michigan (1)
United States (14) · France (7) · Italy (5) · Bulgaria (4) · Germany (4) · Japan (4) · Belgium (3) · Canada (3) · China (3) · Netherlands (3) · Russia (3) · Spain (3) · Thailand (3) · Turkey (Türkiye) (3) · Argentina (2)
Irina Bancos, MD (2) · Abbas A Mansour (1) · Amir Hamrahian, MD (1) · Haider A Alidrisi (1) · Ibrahim H Hussein, MD (1) · Mario Maldonado, MD (1) · Recordati AG (1) · Richard Auchus, MD, PhD (1)
PMID 24107737, PMID 41052284, PMID 39610378, PMID 20837883, PMID 21986283, PMID 24423285, PMID 27454103, PMID 28887710, PMID 29510982, PMID 30817193, PMID 31206616, PMID 32730798, PMID 33074401, PMID 35220871, PMID 35325149, PMID 3536461, PMID 35817047, PMID 36952249, PMID 37318239, PMID 37680892, PMID 37801655, PMID 38696122, PMID 39062179, PMID 39086899, PMID 6135282
2008 (2), 2014 (1), 2018 (1), 2025 (1)