Osilodrostat

Recordati Rare Diseases Announce Publication of Long-term Outcomes From the Extension to the Phase III LINC 3 Study of Isturisa® (Osilodrostat) in Patients With Cushing’s Disease in the European Journal of Endocrinology

Retrieved on: 
Wednesday, August 31, 2022
Research, Managed Care, General Health, Pharmaceutical, Oncology, Hospitals, Science, Surgery, Cardiology, Nursing, Health, Diabetes, Consensus, AES, Safety, Research, Hirsutism, Guru Angad Dev Veterinary and Animal Sciences University, Conditional sentence, Maintenance, Adrenocorticotropic hormone, CYP11B1, Meta-analysis, Osilodrostat, European Journal, Cushing's syndrome, Adult, Endocrinology, Risk, Patient, ISIN, Female, Degenerative disease, OR, Disorder, Manuscript, Oregon Health Plan, Consensus decision-making, Advertising, Pituitary adenoma, EMEA, Reuters, Rare, Neurosurgery, David Ferrier, Quality of life, LINC, Cushing's disease, European Commission, Marketing, Nature, Microdeletion syndrome, Oregon Health & Science University, Phase, Royal commission, Manchester, ULN, The Lancet, III, Uncertainty, Pharmaceutical industry, Silviculture, EU, Diagnosis

Median duration of exposure to Isturisa from core study baseline to end of the extension was 130 weeks (range 1245).

Key Points: 
  • Median duration of exposure to Isturisa from core study baseline to end of the extension was 130 weeks (range 1245).
  • Recordati Rare Diseases is committed to improving the lives of patients with this rare, debilitating and life-threatening condition.
  • Long-term outcomes of osilodrostat in Cushings disease: LINC 3 study extension The European Journal of Endocrinology 2022.
  • Efficacy and safety of osilodrostat in patients with Cushing's disease (LINC 3): a multicentre phase III study with a double-blind, randomised withdrawal phase.

Recordati Rare Diseases Announces Several Scientific Abstracts to Be Presented at the Upcoming Endo Society Annual Meeting

Retrieved on: 
Wednesday, June 8, 2022
Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, ENDO, QT interval, Plasma, Dizziness, Efficacy, Quality of life, Serum, Vomiting, ECG, Hypokalemia, Uncertainty, Hyperandrogenism, Infection, Barrow Neurological Institute, Headache, Advertising, Edema, Awareness, Half-life, Hypotension, Endocrine system, Hypoglycemia, Phase, Diagnosis, MD, Adrenal insufficiency, Patient, Degenerative disease, Hypertension, Nausea, Abdominal pain, Arrhythmia, Symptoms of COVID-19, Adrenocorticotropic hormone, Disease, Incidence, Androgen, Pituitary adenoma, Adult, Research, CYP3A4, Fatigue, Titration, Nature, ACTH, FDA, Mortality, CYP2B6, Risk, Magnesium, Lactation, QT, LINC, Pharmaceutical industry, Medical imaging, Birth control, Osilodrostat, Safety

Recordati Rare Diseases Inc. announced today that various scientific abstracts have been accepted and will be presented onsite at the ENDO 2022 annual meeting being held in Atlanta, Georgia from June 11 14, 2022.

Key Points: 
  • Recordati Rare Diseases Inc. announced today that various scientific abstracts have been accepted and will be presented onsite at the ENDO 2022 annual meeting being held in Atlanta, Georgia from June 11 14, 2022.
  • For more information visit www.isturisa.com
    About Recordati Rare Diseases Inc.
    Recordati Rare Diseases Inc. is a biopharmaceutical company committed to providing often-overlooked orphan therapies to the underserved rare disease communities of the United States.
  • Recordati Rare Diseases mission is to reduce the impact of extremely rare and devastating diseases by providing urgently needed therapies.
  • We work side-by-side with rare disease communities to increase awareness, improve diagnosis and expand availability of treatments for people with rare diseases.

Phase III LINC 3 Study Demonstrates That ISTURISA® (osilodrostat) Improves Physical Features Associated With Hypercortisolism in Patients With Cushing’s Disease

Retrieved on: 
Friday, May 13, 2022
Health, Pharmaceutical, Abdominal pain, Hypokalemia, Lactation, Infection, Magnesium, Hypotension, Mortality, Androgen, Plasma, Osilodrostat, Manchester, Week, Risk, American Association, Headache, Pituitary adenoma, Fatigue, Edema, Medical Affairs Bureau, Serum, Nausea, Cushing's disease, AACE, Arrhythmia, Incidence, Symptoms of COVID-19, Hirsutism, Hypoglycemia, The Lancet, Phase, Quality of life, Nature, Degenerative disease, Research, ACTH, III, Vomiting, Advertising, QT interval, ECG, Dizziness, Adrenal insufficiency, Waist, Uncertainty, Health, Association, Half-life, CYP3A4, Adult, FDA, Hyperandrogenism, Awareness, De novo, CYP2B6, Disease, QT, Microdeletion syndrome, Safety, LINC, Diagnosis, Hypertension, Pharmaceutical industry, Medical imaging, Birth control, Patient

Recordati Rare Diseases Inc. announced today that the Phase III LINC 3 study demonstrates ISTURISA (osilodrostat) improves physical features associated with hypercortisolism in patients with Cushings disease.

Key Points: 
  • Recordati Rare Diseases Inc. announced today that the Phase III LINC 3 study demonstrates ISTURISA (osilodrostat) improves physical features associated with hypercortisolism in patients with Cushings disease.
  • Patients with Cushings disease experience multiple physical manifestations of hypercortisolism that may reduce quality of life.
  • According to the abstract entitled Osilodrostat Therapy Improves Physical Features Associated with Hypercortisolism in Patients with Cushings Disease: Findings from the Phase III LINC 3 Study, 137 adult Cushings disease patients with mUFC >1.5 x the upper limit of normal were enrolled in the 48-week core phase to evaluate the safety and efficacy of ISTURISA in patients with Cushings disease.
  • Changes to physical features caused by Cushings disease can have a significant impact on patient health and well-being.

Recordati Rare Diseases Announce Publication in the Journal of Clinical Endocrinology & Metabolism of the Phase III LINC 4 Study Confirming the Efficacy and Safety of Isturisa® (Osilodrostat) in Patients With Cushing’s Disease

Retrieved on: 
Tuesday, March 29, 2022
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Journal, Adult, Rare, Manchester, Pituitary adenoma, Safety, Microdeletion syndrome, Patient, LINC, Phase, Pharmaceutical industry, EU, Osilodrostat

Improvements in cardiovascular and metabolic parameters of Cushings disease, including blood pressure and blood glucose metabolism, were seen by week 12 and were maintained throughout the study.

Key Points: 
  • Improvements in cardiovascular and metabolic parameters of Cushings disease, including blood pressure and blood glucose metabolism, were seen by week 12 and were maintained throughout the study.
  • Osilodrostat rapidly lowered cortisol excretion to normal in most patients with Cushings disease and maintained normal levels throughout the core phase of the study.
  • Recordati Rare Diseases is committed to improving the lives of patients with this rare, debilitating and life-threatening condition.
  • Efficacy and safety of osilodrostat in patients with Cushing's disease (LINC 3): a multicentre phase III study with a double-blind, randomised withdrawal phase.

RECORDATI: POSITIVE RESULTS FROM THE PHASE III LINC 4 STUDY PRESENTED AT THE ENDOCRINE SOCIETY’S ANNUAL MEETING REINFORCE THE EFFICACY AND SAFETY OF ISTURISA® (OSILODROSTAT) IN CUSHING’S DISEASE

Retrieved on: 
Tuesday, March 23, 2021
Adrenal gland disorders, Chemical compounds, Orphan drugs, Organ systems, Imidazoles, Nitriles, Osilodrostat, Pyrroles, Health, Cushing's syndrome, Cushing's disease, Placebo-controlled study

These data provide further evidence of the benefits of Isturisa as an effective and well-tolerated oral treatment option for patients with Cushings disease.

Key Points: 
  • These data provide further evidence of the benefits of Isturisa as an effective and well-tolerated oral treatment option for patients with Cushings disease.
  • The key secondary endpoint was also met, with the majority (81%) of patients having normal mUFC levels at week 36.
  • We are delighted that the positive and statistically significant data from the LINC 4 study have been presented at the Endocrine Societys Annual Meeting.
  • Osilodrostat is an effective and well-tolerated treatment for Cushing's disease (CD): results from a Phase III study with an upfront, randomized, double-blind, placebo-controlled phase (LINC 4); presented at ENDO 2021, March 2021.

Recordati Rare Diseases: Positive Results From the Phase III LINC 4 Study Presented Today at the Endocrine Society’s Annual Meeting Reinforce the Efficacy and Safety of Isturisa® (osilodrostat) in Cushing’s Disease

Retrieved on: 
Tuesday, March 23, 2021
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Clinical trials, Other Health, Chemical compounds, Orphan drugs, Clinical trials, Imidazoles, Nitriles, Osilodrostat, Pyrroles, Placebo-controlled study, Organic compounds, Medical research

All patients received open-label Isturisa after week 12 until the end of the core study (week 48).

Key Points: 
  • All patients received open-label Isturisa after week 12 until the end of the core study (week 48).
  • We are delighted that the positive and statistically significant data from the LINC 4 study have been presented at The Endocrine Societys Annual Meeting.
  • Osilodrostat is an effective and well-tolerated treatment for Cushings disease (CD): results from a Phase III study with an upfront, randomized, double-blind, placebo-controlled phase (LINC 4).
  • This document contains forward-looking statements relating to future events and future operating, economic and financial results of the Recordati group.

Cushing's Syndrome Pipeline Insight, 2020 Featuring Novartis Pharmaceuticals, Cortendo AB, Corcept Therapeutics and HRA Pharma - ResearchAndMarkets.com

Retrieved on: 
Friday, May 1, 2020
Health, General Health, Chemical compounds, Adrenal gland disorders, Cushing, Organic compounds, Organ systems, Relacorilant, Osilodrostat

This report outlays comprehensive insights of present clinical development scenario and growth prospects across the Cushing's Syndrome market.

Key Points: 
  • This report outlays comprehensive insights of present clinical development scenario and growth prospects across the Cushing's Syndrome market.
  • A detailed picture of the Cushing's Syndrome pipeline landscape is provided, which includes the disease overview and Cushing's Syndrome treatment guidelines.
  • The assessment part of the report embraces in-depth Cushing's Syndrome commercial assessment and clinical assessment of the Cushing's Syndrome pipeline products from the pre-clinical developmental phase to the marketed phase.
  • Cushing's Syndrome key players involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

RECORDATI: ACQUISITION OF WORLDWIDE RIGHTS TO SIGNIFOR® AND OSILODROSTAT (LCI699) COMPLETED

Retrieved on: 
Wednesday, October 23, 2019
Organ systems, Endocrine system, Chemical compounds, Adrenal gland disorders, Adrenal gland, Osilodrostat, Steroid 11β-hydroxylase, Cushing's syndrome, Cortisol, Steroidogenesis inhibitor

The acquisition also covers the worldwide rights to osilodrostat (LCI699), an investigational innovative drug for the treatment of endogenous Cushings syndrome, for which marketing authorization applications have been filed in the European Union and in the USA.

Key Points: 
  • The acquisition also covers the worldwide rights to osilodrostat (LCI699), an investigational innovative drug for the treatment of endogenous Cushings syndrome, for which marketing authorization applications have been filed in the European Union and in the USA.
  • Subsequently, additional milestone payments contingent upon the approval and market access of osilodrostat as well as royalties on sales of this new product, will be due.
  • Osilodrostat is an orally administered steroidogenesis inhibitor of 11Beta-hydroxylase, an enzyme which catalyses the final step of cortisol synthesis in the adrenal cortex.
  • Recordati is committed to the research and development of new specialties with a focus on treatments for rare diseases.

Pituitary ACTH Hypersecretion (Cushing's Disease) - Pipeline Insight, 2019 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, May 8, 2019
Health, Pharmaceutical, Endocrine system, Organ systems, Adrenal gland disorders, Glands, Pituitary ACTH hypersecretion, Cushing's syndrome, Adrenocorticotropic hormone, Cushing's disease, Osilodrostat, Dexamethasone suppression test

The "Pituitary ACTH Hypersecretion (Cushing's Disease) - Pipeline Insight, 2019" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Pituitary ACTH Hypersecretion (Cushing's Disease) - Pipeline Insight, 2019" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • The report offers comprehensive insights of the pipeline (under development) therapeutics scenario and growth prospects across Pituitary ACTH Hypersecretion (Cushing's Disease) development.
  • The report covers pipeline activity across the complete product development cycle i.e.
  • clinical, pre-clinical and discovery stages for Pituitary ACTH Hypersecretion (Cushing's Disease)
    The report provides pipeline product profiles which includes product description, developmental activities, licensors & collaborators and chemical information
    Provides pipeline assessment by monotherapy and combination therapy products, stage of development, route of administration, and molecule type for Pituitary ACTH Hypersecretion (Cushing's Disease)
    Identify the relationship between the drugs and use it for target finding, drug repurposing, and precision medicine