ISTURISA® (osilodrostat) Now Available in Canada for the Treatment of Cushing’s Disease

Posted on January 20, 2026 by MaryO

ISTURISA® (osilodrostat) is indicated for the treatment of adult patients with Cushing’s disease who have persistent or recurrent hypercortisolism after primary pituitary surgery and/or irradiation, or for whom pituitary surgery is not an option.1

TORONTO, Jan. 13, 2026 /CNW/ – Recordati Rare Diseases Canada Inc. announced today the Canadian product availability of ISTURISA® (osilodrostat) for the treatment of adult patients with Cushing’s disease who have persistent or recurrent hypercortisolism following pituitary surgery and/or irradiation, or for whom surgery is not an option.1 This is following the marketing authorisation of ISTURISA® in Canada on July 5, 2025.

Dr. André Lacroix, Professor of Medicine at the University of Montreal and internationally recognized authority in Cushing’s syndrome, commented on the importance of this new treatment option: ” ISTURISA® is an important addition to the treatment options for Cushing’s disease, a rare and debilitating condition. Achieving control of cortisol overproduction is an important strategy in helping patients manage Cushing’s disease.”

ISTURISA’s approval is supported by data from the LINC 3 and LINC 4 Phase III clinical studies, which demonstrated clinically meaningful reductions in mean urinary free cortisol (mUFC) levels and showed a favourable safety profile. ISTURISA® is available as 1 mg, 5 mg, and 10 mg film-coated tablets, enabling individualized titration based on cortisol levels and clinical response.1

About Cushing’s Disease

Cushing disease is a rare disorder of hypercortisolism caused by an adrenocorticotropic hormone (ACTH)-secreting pituitary adenoma, which in turn stimulates the adrenal glands to produce excess cortisol. Prolonged exposure to elevated cortisol levels is associated with substantial morbidity and mortality and impaired quality of life (QoL). Accordingly, normalization of cortisol is the primary treatment goal for Cushing disease.2

About Isturisa®

ISTURISA® is an inhibitor of 11β‐hydroxylase (CYP11B1), the enzyme responsible for the final step of cortisol synthesis in the adrenal gland. ISTURISA® is taken twice daily and is available as 1 mg, 5 mg and 10 mg film‐coated tablets, allowing for individualized titration based on cortisol levels and clinical response. For full prescribing information, healthcare professionals are encouraged to consult the Isturisa Product Monograph at https://recordatirarediseases.com/wp content/uploads/2025/08/ISTURISAProduct-Monograph-English-Current.pdf

Recordati Rare Diseases is Recordati’s dedicated business unit focused on rare diseases. Recordati is an international pharmaceutical Group listed on the Italian Stock Exchange (XMIL: REC), with roots dating back to a family-run pharmacy in Northern Italy in the 1920s. Our fully integrated operations span clinical development, chemical and finished product manufacturing, commercialisation and licensing. We operate in approximately 150 countries across EMEA, the Americas and APAC with over 4,500 employees.

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.

Recordati Rare Diseases Canada Inc. is the company’s Canada offices located inToronto, Ontario, with the North America headquarter offices located in New Jersey, US, and the global headquarter offices located in Milan, Italy.

This document contains forward-looking statements relating to future events and future operating, economic and financial results of the Recordati group. By their nature, forward-looking statements involve risk and uncertainty because they depend on the occurrence of future events and circumstances. Actual results may therefore differ materially from those forecast for a variety of reasons, most of which are beyond the Recordati group’s control. The information on the pharmaceutical specialties and other products of the Recordati group contained in this document is intended solely as information on the activities of the Recordati Group, and, as such, it is not intended as a medical scientific indication or recommendation, or as advertising.

References:
1. Isturisa® Product Monograph. 2025-07-03
2. Gadelha M et al. J Clin Endocrinol Metab. 2022 Jun 16;107(7): e2882-e2895

SOURCE Recordati Rare Diseases Canada Inc.

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Media Relations: spPR Inc., Sonia Prashar, 416.560.6753, Soniaprashar@sppublicrelations.com

https://www.newswire.ca/news-releases/isturisa-r-osilodrostat-now-available-in-canada-for-the-treatment-of-cushing-s-disease-879473023.html

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Insights on Diagnosing and Managing Cushing’s Syndrome

Posted on August 18, 2024 by MaryO

Cushing’s syndrome, or endogenous hypercortisolemia, is a rare condition that both general practice clinicians and endocrinologists should be prepared to diagnose and treat. Including both the pituitary and adrenal forms of the disease, the Endocrine Society estimates that the disorder affects 10 to 15 people per million every year in the United States. It is more common in women and occurs most often in people between the ages of 20 and 50.

Even though Cushing’s remains a rare disease, cortisol recently made waves at the American Diabetes Association 84th Scientific Session. A highlight of the meeting was the initial presentation of data from the CATALYST trial, which assessed the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes (A1c 7.5+).

CATALYST is a prospective, Phase 4 study with two parts. In the prevalence phase, 24% of 1,055 enrolled patients had hypercortisolism, defined as an overnight dexamethasone suppression test (ODST) value greater than 1.8 µg/dL and dexamethasone levels greater than 140 µg/dL. Results of CATALYST’s randomized treatment phase are expected in late 2024.

Elena Christofides, MD, FACE, founder of Endocrinology Associates, Inc., in Columbus, OH, believes the CATALYST results will be a wake-up call for both physicians and patients seeking to advocate for their own health. “This means that nearly 1 in 4 patients with type 2 diabetes have some other underlying hormonal/endocrine dysfunction as the reason for their diabetes, or significant contribution to their diabetes, and they should all be screened,” she said. “All providers need to get comfortable with diagnosing and treating hypercortisolemia, and you need to do it quickly because patients are going to pay attention as well.”

In Dr. Christofides’ experience, patients who suspect they have a hormonal issue may start with their primary care provider or they may self-refer to an endocrinologist. “A lot of Cushing’s patients are getting diagnosed and treated in primary care, which is completely appropriate. But I’ve also met endocrinologists who are uncomfortable diagnosing and managing Cushing’s because it is so rare,” she said. “The important thing is that the physician is comfortable with Cushing’s or is willing to put in the work get comfortable with it.”

According to Dr. Christofides, the widespread popular belief that “adrenal fatigue” is causing millions of Americans to feel sick, tired, and debilitated may be creating barriers to care for people who may actually have Cushing’s. “As physicians, we know that adrenal fatigue doesn’t exist, but we should still be receptive to seeing patients who raise that as a concern,” said Dr. Christofides. “We need to acknowledsalige their lived experience as being very real and it can be any number of diseases causing very real symptoms. If we don’t see these patients, real cases of hypercortisolemia could be left undiagnosed and untreated.”

Dr. Christofides, who also serves as a MedCentral Editor-at-Large, said she reminds colleagues that overnight dexamethasone suppression test (ODST) should always be the first test when you suspect Cushing’s. “While technically a screening test, the ODST can almost be considered diagnostic, depending on how abnormal the result is,” she noted. “But I always recommend that you do the ODST, the ACTH, a.m. cortisol, and the DHEAS levels at the same time because it allows you to differentiate more quickly between pituitary and adrenal problems.”

Dr. Christofides does see a place for 24-hour urine collection and salivary cortisol testing at times when diagnosing and monitoring patients with Cushing’s. “The 24-hour urine is only positive in ACTH-driven Cushing’s, so an abnormal result can help you identify the source, but too many physicians erroneously believe you can’t have Cushing’s if the 24-hour urine is normal,” she explained. “Surgeons tend to want this test before they operate and it’s a good benchmark for resolution of pituitary disease.” She reserves salivary cortisol testing for cases when the patient’s ODST is negative, but she suspects Cushing’s may be either nascent or cyclical.

Surgical resection has long been considered first-line treatment in both the pituitary and adrenal forms of Cushing’s. For example, data shared from Massachusetts General Hospital showed that nearly 90% of patients with microadenomas did not relapse within a 30-year period. A recent study found an overall recurrence rate of about 25% within a 10-year period. When reoperation is necessary, remission is achieved in up to 80% of patients.

As new medications for Cushing’s syndrome have become available, Dr. Christofides said she favors medical intervention prior to surgery. “The best part about medical therapy is you can easily stop it if you’re wrong,” she noted. “I would argue that every patient with confirmed Cushing’s deserves nonsurgical medical management prior to a consideration of surgery to improve their comorbidities and surgical risk management, and give time to have a proper informed consent discussion.”

In general, medications to treat Cushing’s disease rely on either cortisol production blockade or receptor blockade, said Dr. Christofides. Medications that directly limit cortisol production include ketoconazole, osilodrostat (Isturisa), mitotane (Lysodren), levoketoconazole (Recorlev), and metyrapone (Metopirone). Mifepristone (Korlym, Mifeprex) is approved for people with Cushing’s who also have type 2 diabetes to block the effects of cortisol. Mifepristone does not lower the amount of cortisol the body makes but limits its effects. Pasireotide (Signifor) lowers the amount of ACTH from the tumor. Cabergoline is sometimes used off-label in the US for the same purpose.

Following surgery, people with Cushing’s need replacement steroids until their adrenal function resumes, when replacement steroids must be tapered. But Dr. Christofides said she believes that all physicians who prescribe steroids should have a clear understanding of when and how to taper patients off steroids.

“Steroid dosing for therapeutic purposes is cumulative in terms of body exposure and the risk of needing to taper. A single 2-week dose of steroids in a year does not require a taper,” she said. “It’s patients who are getting repeated doses of more than 10 mg of prednisone equivalent per day for 2 or more weeks multiple times per year who are at risk of adrenal failure without tapering.”

Physicians often underestimate how long a safe, comfortable taper can take, per Dr. Christofides. “It takes 6 to 9 months for the adrenals to wake up so if you’re using high-dose steroids more frequently, that will cause the patient to need more steroids more frequently,” she explained. “If you’re treating an illness that responds to steroids and you stop them without tapering, the patient’s disease will flare, and then a month from then to 6 weeks from then you’ll be giving them steroids again, engendering a dependence on steroids by doing so.”

When developing a steroid taper plan for postoperative individuals with Cushing’s (and others), Dr. Christofides suggests basing it on the fact that 5 mg of prednisone or its equivalent is the physiologic dose. “Reduce the dose by 5 mg per month until you get to the last 5 mg, and then you’re going to reduce it by 1 mg monthly until done,” she said. “If a patient has difficulty during that last phase, consider a switch to hydrocortisone because a 1 mg reduction of hydrocortisone at a time may be easier to tolerate.”

Prednisone, hydrocortisone, and the other steroids have different half-lives, so you’ll need to plan accordingly, adds Dr. Christofides. “If you do a slower taper using hydrocortisone, the patient might feel worse than with prednisone unless you prescribe it BID.” She suggests thinking of the daily prednisone equivalent of hydrocortisone as 30 mg to allow for divided dosing, rather than the straight 20 mg/day conversion often used.

What happens after a patient’s Cushing’s has been successfully treated? Cushing’s is a chronic disease, even in remission, Dr. Christofides emphasized. “Once you have achieved remission, my general follow-up is to schedule visits every 6 months to a year with scans and labs, always with the instruction if the patient feels symptomatic, they should come in sooner,” she said.

More on Cushing’s diagnosis and therapies.

https://www.medcentral.com/endocrinology/cushings-syndrome-a-clinical-update

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Results Reinforce Efficacy of Recordati’s Isturisa in Cushing’s Disease

Posted on June 22, 2022 by MaryO

Recordati Rare Diseases, a US biopharma that forms part of the wider Italian group, has presented multiple positive data sets on Isturisa (osilodrostat) at the annual ENDO 2022 meeting in Atlanta, Georgia.

Isturisa is a cortisol synthesis inhibitor indicated for the treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.

Among the data presented, the Phase III LINC 4 study demonstrated that Isturisa maintained normal mean urinary free cortisol long-term in patients with Cushing’s disease while the Phase III LINC 3 study found adrenal hormone levels changed during early treatment with the drug while stabilizing during long-term treatment.

The ILLUSTRATE study also showed patients treated with a prolonged titration interval tended to have greater persistence with therapy.

Mohamed Ladha, president and general manager for North America, Recordati Rare Diseases, said: “The data from these studies reinforces the efficacy and safety of Isturisa as a treatment for patients with Cushing’s disease.

“We are pleased to share these data with the endocrine community and are excited to provide patients with a much-needed step forward in the management of this rare, debilitating, and potentially life-threatening condition.”

Cushing’s disease is a rare, serious illness caused by a pituitary tumor that leads to overproduction of cortisol by the adrenal glands. Excess cortisol can contribute to an increased risk of morbidity and mortality. Treatment for the condition seeks to lower cortisol levels to a normal range.

Isturisa, which was approved by the US Food and Drug Administration in March 2020, works by inhibiting 11-beta-hydroxylase, an enzyme responsible for the final step of cortisol biosynthesis in the adrenal gland.

From https://www.thepharmaletter.com/article/results-reinforce-efficacy-of-recordati-s-isturisa-in-cushing-s-disease

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Medications Used to Treat Cushing’s

Posted on June 13, 2022 by MaryO

Dr. Friedman uses several medications to treat Cushing’s syndrome that are summarized in this table. Dr. Friedman especially recommends ketoconazole. An in-depth article on ketoconazole can be found on goodhormonehealth.com.

 

 

 Drug How it works Dosing Side effects
Ketoconazole  (Generic, not FDA approved in US) blocks several steps in cortisol biosynthesis Start 200 mg at 8 and 10 PM, can up titrate to 1200 mg/day • Transient increase in LFTs
• Decreased testosterone levels
• Adrenal insufficiency
Levoketoconazole (Recorlev) L-isomer of Ketoconazole Start at 150 mg at 8 and 10 PM, can uptitrate up to 1200 mg nausea, vomiting, increased blood pressure, low potassium, fatigue, headache, abdominal pain, and unusual bleeding
Isturisa (osilodrostat) blocks 11-hydroxylase 2 mg at bedtime, then go up to 2 mg at 8 and 10 pm, can go up to 30 mg  Dr. Friedman often gives with spironolactone or ketoconazole. • high testosterone (extra facial hair, acne, hair loss, irregular periods)  • low potassium
• hypertension
Cabergoline (generic, not FDA approved) D2-receptor agonist 0.5 to 7 mg • nausea,  • headache  • dizziness
Korlym (Mifepristone) glucocorticoid receptor antagonist 300-1200 mg per day • cortisol insufficiency (fatigue, nausea, vomiting, arthralgias, and headache)
• increased mineralocorticoid effects (hypertension, hypokalemia, and edema
• antiprogesterone effects (endometrial thickening)
Pasireotide (Signafor) somatostatin receptor ligand 600 μg or 900 μg twice a day Diabetes, hyperglycemia, gallbladder issues

For more information or to schedule an appointment with Dr. Friedman, go to goodhormonehealth.com

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Osilodrostat Resolves Most Physical Signs of Cushing’s Disease

Posted on May 18, 2022 by MaryO

— More than half of patients saw physical manifestations fully resolve by week 72

by Kristen Monaco, Staff Writer, MedPage Today May 16, 2022

SAN DIEGO — Osilodrostat (Isturisa) improved many physical features associated with Cushing’s disease, according to additional findings from the phase III LINC-3 study.

Among 137 adults with Cushing’s disease, a 39.5% improvement in central obesity scores was observed from baseline to week 72 with osilodrostat, reported Alberto Pedroncelli, MD, PhD, of Recordati AG in Basel, Switzerland.

Not only was central obesity the most common physical manifestation associated with hypercortisolism among these Cushing’s disease patients, but it was also more frequently rated as severe at baseline, Pedroncelli explained during the American Association of Clinical Endocrinology (AACE) annual meeting.

Osilodrostat treatment also led to a 34.9% improvement in proximal muscle atrophy at week 72, along with a 34.4% improvement in hirsutism scores.

By week 72, nearly all physical manifestations of hypercortisolism saw significant improvement — marked by more than 50% of patients scoring these physical traits as nonexistent:

  • Dorsal fat pat: 50.6%
  • Central obesity: 30.6%
  • Supraclavicular fat pad: 51.8%
  • Facial rubor: 64.7%
  • Hirsutism in women: 53.1%
  • Proximal muscle atrophy: 61.2%
  • Striae: 63.5%
  • Ecchymoses: 87.1%

Most of these physical manifestation improvements were notable soon after treatment initiation with osilodrostat, Pedroncelli pointed out.

When stratified according to testosterone levels, hirsutism scores remained either stable or improved in the majority of patients who had normal or above normal testosterone levels. More women with normal testosterone levels over time experienced improvements in hirsutism versus those with levels above the upper limit of normal, who mostly remained stable.

Osilodrostat is an oral agent that was first FDA approved in March 2020 for adults with Cushing’s disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease. Available in 1 mg, 5 mg, and 10 mg film-coated tablets, the drug acts as a potent oral 11-beta-hydroxylase inhibitor — the enzyme involved in the last step of cortisol synthesis.

Osilodrostat is taken orally twice daily, once in the morning and once in the evening.

Approval was based upon findings from the LINC-3 and LINC-4 trials, which found osilodrostat was able to normalize cortisol levels in 53% of patients, based on mean 24-hour urinary free cortisol (UFC) concentrations. During an initial 10-week randomization phase, 86% of patients maintained their complete cortisol response if they remained on osilodrostat versus only 29% of those who were switched to placebo.

As expected, 77.4% of the 137 adults included in the trial were women. The median participant age was 40 and about 47 months had passed since their initial diagnosis. A total of 87.6% underwent previous pituitary surgery and 16.1% underwent previous pituitary irradiation. At baseline, median and mean 24-hour UFC levels were 3.5 nmol and 7.3 nmol, respectively, based on two or three urine samples.

Participants had an average body weight of 176.4 lb, body mass index (BMI) of 30, and 41 in waist circumference at baseline. Throughout the trial, all measures dropped, reaching the nadir at week 72: body weight of 165 lb, BMI of 27, and 37.8 in waist circumference.

The most common side effects reported with the agent include adrenal insufficiency, fatigue, nausea, headache, and edema.

  • author['full_name']

    Kristen Monaco is a staff writer, focusing on endocrinology, psychiatry, and nephrology news. Based out of the New York City office, she’s worked at the company since 2015.

Disclosures

The study was supported by Recordati AG.

Pedroncelli reported employment with Recordati.

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