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Cushing's drug osilodrostat under Long-Term safety review

NCT ID NCT05382156

Disease control Sponsor: RECORDATI GROUP Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study follows 206 patients with Cushing's syndrome who are taking osilodrostat (Isturisa) to see how safe and effective it is over time. Researchers will track side effects and how well the drug controls cortisol levels. No new treatment is given—just real-world monitoring.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Osilodrostat (Isturisa), a drug that lowers cortisol levels
What this could lead to
If successful, this study will confirm that osilodrostat is safe and effective for long-term control of Cushing's syndrome, helping doctors manage the disease better.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It only includes patients already on the drug, so it cannot prove cause and effect.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

206 people

The number who actually took part.

Started

Jun 2022

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The patient population will consist of adult male and female patients with endogenous Cushing's Syndrome. Eligible patients for the study must be treated with osilodrostat. Investigators need to ensure that patients enrolled in this study meet the study inclusion and exclusion criteria listed in the protocol.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Written informed consent obtained prior to registration of any patient data * Male or female patients aged 18 years or older with endogenous CS treated with osilodrostat. Treatment with osilodrostat can either be initiated at the first visit of the study or can have been initiated before screening. Exclusion Criteria: * Patients with exogenous CS * Patients with Pseudo CS * Patients participating in an interventional clinical trial with an investigational drug.

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Conditions

The condition(s) this trial relates to.

Cushing syndrome endogenous Cushing syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endogenous Cushing's syndrome

Contacts and locations

Locations

  • Amedes Experts

    Hamburg, 20095, Germany

  • Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

    Roma, 00189, Italy

  • Azienda Ospedaliera Universitaria "Federico II"

    Naples, 80131, Italy

  • Azienda Ospedaliero Universitaria Ospedali Riuniti

    Ancona, 60126, Italy

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013, United States

  • CHU de Grenoble site Nord

    Grenoble, 38043, France

  • CHU de Nantes-Hopital Laennec

    Nantes, 44800, France

  • Charité Universitaetsmedizin Berlin

    Berlin, 10117, Germany

  • Emory University School

    Atlanta, Georgia, 30322, United States

  • Endocrinology Research Associates, Inc.

    Columbus, Ohio, 43201, United States

  • Endokrinologikum Frankfurt

    Frankfurt, 60596, Germany

  • Erasmus MC

    Rotterdam, 3015 GD, Netherlands

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Froedtert Hospital

    Milwaukee, Wisconsin, 53226, United States

  • Groupement Hospitalier Sud - Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94275, France

  • Hopital Claude Huriez - CHRU Lille

    Lille, 59037, France

  • Hopital Larrey

    Toulouse, 31000, France

  • Hopital de la Conception - APHM

    Marseille, 13005, France

  • Hospices Civiles de Lyon

    Bron, 69677, France

  • Hôpital Cochin

    Paris, 75679, France

  • Hôpital Haut-Lévêque

    Bordeaux, 33604, France

  • Hôpital de Brabois

    Nancy, 54500, France

  • Indiana University Schl-med

    Indianapolis, Indiana, 46202, United States

  • Ludwig-Maximilians University of Munich

    Munich, Germany

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114-2696, United States

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905, United States

  • Medicover Berlin-Mitte MVZ

    Berlin, 10117, Germany

  • Medicover Köln

    Cologne, 50939, Germany

  • Medicover MVZ Oldenburg

    Oldenburg, 26122, Germany

  • Medicover Neuroendokrinologie

    Munich, 81667, Germany

  • Memorial Sloan-Kettering Cancer Center (MSKCC) - New York

    New York, New York, 10021, United States

  • NYU Grossman School of Medicine

    New York, New York, 10017, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Oregon Health And Science University

    Portland, Oregon, 97239, United States

  • Policlinico Umberto I

    Roma, 00186, Italy

  • Radboud University Nijmegen

    Nijmegen, 6500, Netherlands

  • St Elizabeth Physicians

    Covington, Kentucky, 41011, United States

  • Universitaet Bielefeld - Klinikum Bielefeld - Mitte

    Düsseldorf, Germany

  • Universitaetsklinikum Frankfurt Goethe-Universitaet

    Frankfurt, 60590, Germany

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97080, Germany

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States