osilodrostat

DRUG11 trials

Sponsors

Novartis Pharmaceuticals, RECORDATI GROUP, University of Michigan, University of Basrah

Conditions

AIMAHAdrenal AdenomaAdrenal CarcinomaAdrenal InsufficiencyCushing Disease Due to Increased ACTH SecretionCushing SyndromeCushing's DiseaseCushing's Syndrome

Phase 1

A Phase 1 Study of Osilodrostat (LCI699) in Healthy Volunteers and Subjects With Impaired Hepatic Function

CompletedNCT02372084

Novartis PharmaceuticalsHepatic Impairment

Start: 2015-04-21End: 2016-05-19Updated: 2020-12-19

A Phase I Study of Osilodrostat (LCI699) in Healthy Volunteers and Subjects With Impaired Renal Function

CompletedNCT02399202

Novartis PharmaceuticalsRenal Impairment

Start: 2015-11-06End: 2016-03-21Updated: 2020-12-19

Phase 2

Study of Efficacy and Safety of Osilodrostat in Cushing's Syndrome

CompletedNCT02468193

Novartis PharmaceuticalsAdrenal Adenoma, Adrenal Carcinoma, AIMAH +3

Start: 2015-09-24End: 2018-10-29Updated: 2020-05-06

Roll-over Study in Patients With Endogenous Cushing's Syndrome for LCI699

CompletedNCT03606408

RECORDATI GROUPCushing's Syndrome

Start: 2018-10-05End: 2023-11-16Updated: 2024-12-18

Phase 3

Safety and Efficacy of LCI699 for the Treatment of Patients With Cushing's Disease

CompletedNCT02180217

Novartis PharmaceuticalsCushings Disease

Start: 2014-10-06End: 2019-12-04Updated: 2021-01-06

Efficacy and Safety Evaluation of Osilodrostat in Cushing's Disease

CompletedNCT02697734

Novartis PharmaceuticalsCushing's Disease

Start: 2016-10-03End: 2020-12-31Updated: 2021-11-01

Phase 4

Osilodrostat in Patients With Hypertension Caused by Hypercortisolaemia Due to Cushing's Syndrome

Not yet recruitingNCT07247162

RECORDATI GROUPCushing Syndrome, Hypercortisolemia, Hypertension

Start: 2026-08-31End: 2028-07-31Target: 63Updated: 2025-12-10

Combination Osilodrostat and Cabergoline in Cushing's Disease

Enrolling by invitationNCT07603466

University of BasrahCushing Disease Due to Increased ACTH Secretion

Start: 2026-05-11End: 2028-08-01Target: 50Updated: 2026-05-22

Unknown Phase

Non-interventional Study on Osilodrostat in Patients With Endogenous Cushing's Syndrome

Active, not recruitingNCT05382156

RECORDATI GROUPEndogenous Cushing's Syndrome

Start: 2022-06-13End: 2027-08-31Updated: 2025-11-20

Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's Syndrome

CompletedNCT05633953

RECORDATI GROUPCushing's Syndrome

Start: 2023-01-16End: 2023-10-30Updated: 2025-02-10

A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement

RecruitingNCT06430528

University of MichiganAdrenal Insufficiency, Endogenous Cushing Syndrome, Hypercortisolism

Start: 2024-07-19End: 2028-01-01Target: 12Updated: 2026-09-09

Related Papers

Real-world osilodrostat effectiveness and safety in non-pituitary Cushing syndrome.

2025-11-191 citations

Osilodrostat dose impact on efficacy/safety in Cushing's disease: large, pooled analysis of LINC 2, 3, and 4.

2025-10-011 citations

SUN-071 Long-term Safety and Effectiveness of Osilodrostat in Patients with Cushing’s Disease in the LINC Rollover Study

Journal of the Endocrine Society2025-10-01

SUN-054 Long-Term, Real-World, Safety and Effectiveness of Osilodrostat In Patients With Pituitary and Non-Pituitary Cushing’s Syndrome: 2-Year Interim Data From LINC 6

Journal of the Endocrine Society2025-10-01

Improved Clinical Outcomes During Long-term Osilodrostat Treatment of Cushing Disease With Normalization of Late-night Salivary Cortisol and Urinary Free Cortisol

Journal of the Endocrine Society2024-11-1212 citations

7790 A Non-interventional, Multinational, Phase IV Study to Evaluate the Long-Term Safety and Efficacy of Osilodrostat in Patients with Endogenous Cushing's Syndrome (LINC 6): 1-Year Real-World Interim Analysis

Journal of the Endocrine Society2024-10-012 citations

12275 Effect Of Osilodrostat On Cardiovascular And Metabolic Manifestations Of Hypercortisolism In Patients With Non-Pituitary Cushing’s Syndrome: Findings From A Retrospective Observational Study (LINC 7)

Journal of the Endocrine Society2024-10-012 citations

6907 Continued Improvements in Hypertension and Diabetes During Long-Term Osilodrostat Therapy in Patients with Cushing’s Disease: A Pooled Analysis from the Phase III LINC 3 and LINC 4 Studies

Journal of the Endocrine Society2024-10-011 citations

7236 Long Term Extension of Osilodrostat Therapy in Canadian Patients with Cushing’s Disease Benefiting from the LINC 3 and LINC 4 Studies

Journal of the Endocrine Society2024-10-01

SAT-671 Safety And Effectiveness Of Osilodrostat In Patients With Non-Pituitary Cushing’s Syndrome: Results From The Retrospective Observational LINC 7 Study

Journal of the Endocrine Society2024-10-01

Osilodrostat treatment in patients with Cushing's disease of Asian or non-Asian origin: a pooled analysis of two Phase III randomized trials (LINC 3 and LINC 4).

2024-08-2310 citations

Improvement in clinical features of hypercortisolism during osilodrostat treatment: findings from the Phase III LINC 3 trial in Cushing's disease.

2024-05-028 citations

THU041 Clinical Improvements In Patients With Cushing’s Disease Treated With Osilodrostat According To Urinary And Late-night Salivary Cortisol Levels: Pooled Analysis From LINC 3 And LINC 4

Journal of the Endocrine Society2023-10-011 citations

THU032 Osilodrostat Is Effective And Well Tolerated In Patients Of Asian And Non-Asian Origin With Cushing's Disease: A Pooled Analysis From LINC 3 And LINC 4

Journal of the Endocrine Society2023-10-01

THU038 Osilodrostat Dosing In Cushing’s Disease: A Pooled Analysis Of The LINC Program

Journal of the Endocrine Society2023-10-01

Long-term efficacy and safety of osilodrostat in patients with Cushing’s disease: results from the LINC 4 study extension

Frontiers in Endocrinology2023-08-2335 citations

PMON162 Osilodrostat Provides Sustained Clinical Benefits and Improves Health-Related Quality of Life in Patients with Cushing's Disease: Results from the Phase III LINC 4 Study

Journal of the Endocrine Society2022-11-01

PMON160 Improvements in Clinical Signs of Hypercortisolism and Quality of Life According to Urinary and Late-Night Salivary Cortisol Levels in Patients with Cushing's Disease Treated with Osilodrostat

Journal of the Endocrine Society2022-11-01

PMON163 Effect of Osilodrostat on Androgens and Adrenal Hormones in Patients With Cushing's Disease: Long-Term Findings From the Phase III, Prospective LINC 3 Study

Journal of the Endocrine Society2022-11-01

OR27-3 Long-Term Results from the Phase III LINC 4 Study: Osilodrostat Maintained Normal Mean Urinary Free Cortisol in Patients with Cushing's Disease, with a Favorable Safety Profile

Journal of the Endocrine Society2022-11-01

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