Isturisa

(Osilodrostat)

ApprovedSmall molecule

Isturisa is one of 36 small molecule programs targeting Mild Autonomous Cortisol Secretion (MACS). It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Mild Autonomous Cortisol Secretion (MACS)Recruiting

HypertensionNot yet recruiting

Autonomous Cortisol SecretionRecruiting

Mild Autonomous Cortisol Secretion (MACS)Phase 2

Recruiting

HypertensionApproved

Not yet recruiting

Autonomous Cortisol SecretionApproved

Recruiting

Competition

Competitive Landscape

157 competitors in Hypertension

#DrugCompanyPhaseTrials

Baxfendy

AstraZeneca

Phase 3

3 2

Nitrostat

VViatris Specialty LLC

Phase 3

5 3

Isturisa

RRECORDATI GROUP

Approved

1 4

Alka-Seltzer

AAbbott

Phase 3

1 5

Minocycline /d

UUniversity of Florida

Phase 3

1 6

SGLT2

PProf. Dr. med. Ingo Eitel

Phase 3

1 7

HCP1803-3

Hanmi Pharmaceutical Company Limited

Phase 3

1 8

Avastin

Roche

Preclinical

1 9

Winrevair

Alphagan

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Recruiting

Mild Autonomous Cortisol Secretion (MACS)

NCT07104812

Q3 2027

Active, not recruiting

Endogenous Cushing's Syndrome

NCT05382156

Q4 2027

Post-ApprovalRecruiting

Autonomous Cortisol Secretion

NCT07268222

Q1 2028

Recruiting

Cushing's Syndrome

NCT06430528

Clinical

Trials by Indication[1]

Autonomous Cortisol Secretion2 trials

Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)

Recruiting·JJohns Hopkins University·Phase 4·NCT07247058·10 enrolled

Metyrapone Versus Osilodrostat in Patients With Metabolic Autonomous Cortisol Secretion (MACS)

Recruiting·LLaikο General Hospital, Athens·Phase 4·NCT07268222·150 enrolled

Cushing's Syndrome2 trials

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

Completed·RRECORDATI GROUP··NCT05633953·103 enrolled

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

Recruiting·UUniversity of Michigan··NCT06430528·12 enrolled

Efficacy and Safety2 trials

Efficacy and Safety Evaluation of Osilodrostat in Cushing's Disease

Completed· Novartis logo

Novartis·Phase 3·NCT02697734·73 enrolled

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

Completed· Novartis logo

Novartis·Phase 2·NCT02468193·9 enrolled

Endogenous Cushing's Syndrome2 trials

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

Completed·RRECORDATI GROUP·Phase 2·NCT03606408·127 enrolled

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

Active, not recruiting·RRECORDATI GROUP··NCT05382156·206 enrolled

Safety and Efficacy1 trial

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

Completed· Novartis logo

Novartis·Phase 3·NCT02180217·137 enrolled

4 more indications

Mild Autonomous Cortisol Secretion (MACS)1 trial

Impact of 1 mg Osilodrostat Therapy on Mild Autonomous Cortisol Secretion (MACS)

Recruiting·MMayo Clinic·Phase 2·NCT07104812·15 enrolled

Hepatic Function1 trial

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

Completed· Novartis logo

Novartis·Phase 1·NCT02372084·33 enrolled

Hypertension1 trial

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

Not yet recruiting·RRECORDATI GROUP·Phase 4·NCT07247162·63 enrolled

Impaired Renal Function1 trial

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

Completed· Novartis logo

Novartis·Phase 1·NCT02399202·15 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 6, 2020

ISTURISA

NDA NDA212801

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for Osilodrostat. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Osilodrostat compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Osilodrostat. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA212801). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Isturisa. U.S. Food & Drug Administration.
[6]
SEC EDGAR — RECORDATI GROUP company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: RRECORDATI GROUP

Patent Landscape[5]

Patent Cliff

Mar 27, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8835646Aug 23, 2026

8314097Mar 27, 2029

8609862Jan 13, 2031

9434754Jan 13, 2031

10143680Jul 6, 2035

1 more patents

10709691Oct 12, 2035

Isturisa

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q3 2027

Q4 2027

Q1 2028

Trials by Indication[1]

Autonomous Cortisol Secretion2 trials

Cushing's Syndrome2 trials

Efficacy and Safety2 trials

Endogenous Cushing's Syndrome2 trials

Safety and Efficacy1 trial

Mild Autonomous Cortisol Secretion (MACS)1 trial

Hepatic Function1 trial

Hypertension1 trial

Impaired Renal Function1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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