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

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Transsphenoidal Surgery Leads to Remission in Children with Cushing’s Disease

Posted on January 19, 2026 by MaryO

Transsphenoidal surgery — a minimally invasive surgery for removing pituitary tumors in Cushing’s disease patients — is also effective in children and adolescents with the condition, leading to remission with a low rate of complications, a study reports.

The research, “Neurosurgical treatment of Cushing disease in pediatric patients: case series and review of literature,” was published in the journal Child’s Nervous System.

Transsphenoidal (through the nose) pituitary surgery is the main treatment option for children with Cushing’s disease. It allows the removal of pituitary adenomas without requiring long-term replacement therapy, but negative effects on growth and puberty have been reported.

In the study, a team from Turkey shared its findings on 10 children and adolescents (7 females) with the condition, who underwent microsurgery (TSMS) or endoscopic surgery (ETSS, which is less invasive) — the two types of transsphenoidal surgery.

At the time of surgery, the patients’ mean age was 14.8 years, and they had been experiencing symptoms for a mean average of 24.2 months. All but one had gained weight, with a mean body mass index of 29.97.

Their symptoms included excessive body hair, high blood pressure, stretch marks, headaches, acne, “moon face,” and the absence of menstruation.

The patients were diagnosed with Cushing’s after their plasma cortisol levels were measured, and there was a lack of cortical level suppression after they took a low-dose suppression treatment. Measurements of their adrenocorticotropic (ACTH) hormone levels then revealed the cause of their disease was likely pituitary tumors.

Magnetic resonance imaging (MRI) scans, however, only enabled tumor localization in seven patients: three with a microadenoma (a tumor smaller than 10 millimeters), and four showed a macroadenoma.

CD diagnosis was confirmed by surgery and the presence of characteristic pituitary changes. The three patients with no sign of adenoma on their MRIs showed evidence of ACTH-containing adenomas on tissue evaluation.

Eight patients underwent TSMS, and 2 patients had ETSS, with no surgical complications. The patients were considered in remission if they showed clinical adrenal insufficiency and serum cortisol levels under 2.5 μg/dl 48 hours after surgery, or a cortisol level lower than 1.8 μg/dl with a low-dose dexamethasone suppression test at three months post-surgery. Restoration of normal plasma cortisol variation, eased symptoms, and no sign of adenoma in MRI were also requirements for remission.

Eight patients (80%) achieved remission, 4 of them after TSMS. Two patients underwent additional TSMS for remission. Also, 1 patient had ETSS twice after TSMS to gain remission, while another met the criteria after the first endoscopic surgery.

The data further showed that clinical recovery and normalized biochemical parameters were achieved after the initial operation in 5 patients (50%). Three patients (30%) were considered cured after additional operations.

The mean cortisol level decreased to 8.71 μg/dl post-surgery from 23.435 μg/dl pre-surgery. All patients were regularly evaluated in an outpatient clinic, with a mean follow-up period of 11 years.

Two patients showed pituitary insufficiency. Also, 2 had persistent hypocortisolism — too little cortisol — one of whom also had diabetes insipidus, a disorder that causes an imbalance of water in the body. Radiotherapy was not considered in any case.

“Transsphenoidal surgery remains the mainstay therapy for CD [Cushing’s disease] in pediatric patients as well as adults,” the scientists wrote. “It is an effective treatment option with low rate of complications.”

 

From https://cushingsdiseasenews.com/2019/01/15/transsphenoidal-surgery-enables-cushings-disease-remission-pediatric-patients-study/

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Myth: “Each Person Requires the Same Dose of Steroid in Order to Survive…

Posted on January 19, 2026 by MaryO

Myth: “Each person requires the same dose of steroid in order to survive with Secondary or Primary Adrenal Insufficiency”

myth-busted

Fact: In simple terms, Adrenal Insufficiency occurs when the body does not have enough cortisol in it. You see, cortisol is life sustaining and we actually do need cortisol to survive. You have probably seen the commercials about “getting rid of extra belly fat” by lowering your cortisol. These advertisements make it hard for people to actually understand the importance of the function of cortisol.

After a Cushing’s patient has surgery, he/she goes from having very high levels of cortisol to no cortisol at all. For pituitary patients, the pituitary, in theory, should start working eventually again and cause the adrenal glands to produce enough cortisol. However, in many cases; the pituitary gland does not resume normal functioning and leaves a person adrenally insufficient. The first year after pit surgery is spent trying to get that hormone to regulate on its own normally again. For a patient who has had a Bilateral Adrenalectomy (BLA), where both adrenal glands are removed as a last resort to “cure” Cushing’s; his/her body will not produce cortisol at all for his/her life. This causes Primary Adrenal Insufficiency.

All Cushing’s patients spend time after surgery adjusting medications and weaning slowly from steroid (cortisol) to get the body to a maintenance dose, which is the dose that a “normal” body produces. This process can be a very long one. Once on maintenance, a patient’s job is not over. He/She has to learn what situations require even more cortisol. You see, cortisol is the stress hormone and also known as the Fight or Flight hormone. Its function is to help a person respond effectively to stress and cortisol helps the body compensate for both physical and emotional stress. So, when faced with a stressor, the body will produce 10X the baseline levels in order to compensate. When a person can not produce adequate amounts of cortisol to compensate, we call that Adrenal Insufficiency. If it gets to the point of an “Adrenal Crisis”, this means that the body can no longer deal and will go into shock unless introduced to extremely high levels of cortisol, usually administered through an emergency shot of steroid.

There are ways to help prevent a crisis, by taking more steroid than the maintenance dose during times of stress. This can be anything from going to a family function (good stress counts too) to fighting an infection or illness. Acute stressors such as getting into a car accident or sometimes even having a really bad fight require more cortisol as well.

It was once believed that everyone responded to every stressor in the exact same way. So, there are general guidelines about how much more cortisol to introduce to the body during certain stressors. For instance, during infection, a patient should take 2-3X the maintenance dose of steroid (cortisol). Also, even the maintenance dose was considered the same for everyone. Now a days, most doctors will say that 20 mg of Hydrocortisone (Steroid/Cortisol) is the appropriate maintenance dose for EVERYONE. Now, we know that neither is necessarily true. Although the required maintenance dose is about the same for everyone; some patients require less and some require more. I have friends who will go into an adrenal crisis if they take LESS than 30 mg of daily steroid. On the other hand, 30 mg may be way too much for some and those folks may even require LESS daily steroid, like 15 mg. Also, I want to stress (no pun intended) that different stressors affect different people differently. For some, for instance, an acute scare may not affect them. However, for others, receiving bad news or being in shock WILL put their bodies into crisis. That person must then figure out how much additional steroid is needed.

Each situation is different and each time may be different. Depending on the stressor, a person may need just a little more cortisol or a lot. Every person must, therefore, learn their own bodies when dealing with Adrenal Insufficiency. This is VERY important! I learned this the hard way. As a Clinical Psychologist; I assumed that my “coping skills” would be enough to prevent a stressor from putting me into crisis. That was FAR from the truth! I have learned that I can not necessarily prevent my body’s physiological response to stress. People often ask me, “BUT you are a psychologist! Shouldn’t you be able to deal with stress?!!!!” What they don’t realize is that my BODY is the one that has to do the job of compensating. Since my body can not produce cortisol at all, my job is to pay close attention to it so that I can take enough steroid to respond to any given situation. We all have to do that. We all have to learn our own bodies. This is vitally important and will save our lives!

To those we have lost in our community to Adrenal Insufficiency after treatment of Cushing’s, Rest in Peace my friends! Your legacies live on forever!

~ By Karen Ternier Thames

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Study Examines Therapy Options for Post-adrenalectomy Low Glucocorticoid Levels

Posted on January 12, 2026 by MaryO

Hydrocortisone and prednisone have comparable safety and effectiveness when used as glucocorticoid replacement therapy in patients with adrenal adenoma or Cushing’s disease who underwent adrenalectomy, a new study shows.

The study, “Comparison of hydrocortisone and prednisone in the glucocorticoid replacement therapy post-adrenalectomy of Cushing’s Syndrome,” was published in the journal Oncotarget.

The symptoms of Cushing’s syndrome are related to excessive levels of glucocorticoids in our body. Glucocorticoids are a type of steroid hormones produced by the adrenal gland. Consequently, a procedure called adrenalectomy – removal of the adrenal glands – is usually conducted in patients with Cushing’s syndrome.

Unfortunately, adrenalectomy leads to a sharp drop in hormones that are necessary for our bodies. So, post-adrenalectomy glucocorticoid replacement therapy is required for patients.

Hydrocortisone and prednisone are synthetic glucocorticoids that most often are used for glucocorticoid replacement therapy.

Treatment with either hydrocortisone or prednisone has proven effective in patients with Cushing’s syndrome. However, few studies have compared the two treatments directly to determine if there are significant advantages of one therapy over another.

Chinese researchers set out to compare the effectiveness and safety of hydrocortisone and prednisone treatments in patients with Cushing’s syndrome, up to six months after undergoing adrenalectomy.

Patients were treated with either hydrocortisone or prednisone starting at day two post-adrenalectomy. The withdrawal schedule varied by individual patients.

At baseline, both groups had similar responses to the adrenalectomy, including the correction of hypertension (high blood pressure), hyperglycemia (high blood glucose levels), and hypokalemia (low potassium levels). Furthermore, most patients in both groups lost weight and showed significant improvement, as judged by a subjective evaluation questionnaire.

Hydrocortisone did show a significant advantage over prednisone in the improvement of liver function, but its use also was associated with significant swelling of the lower extremities, as compared to prednisone.

Patients in both groups went on to develop adrenal insufficiency (AI) during glucocorticoid withdrawal. However, there were no significant differences in the AI incidence rate – 35 percent in the hydrocortisone group versus 45 percent in the prednisone group. The severity of A also was not significantly different between the groups.

Furthermore, most of the AI symptoms were relieved by going back to the initial doses of the glucocorticoid replacement.

As there were no significant differences between the two treatments, the findings support “the use of both hydrocortisone and prednisone in the glucocorticoid replacement therapy post-adrenalectomy for patients of adrenal adenoma or Cushing’s disease,” researchers concluded.

From https://cushingsdiseasenews.com/2018/01/11/post-adrenalectomy-glucocorticoid-replacement-therapy/

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Cushing’s Disease: When Symptoms Are Mistaken for Menopause

Posted on January 11, 2026 by MaryO

After 8 years of menopause-like symptoms, a 62 year old patient discovered she actually had Cushing’s disease. Read about her long journey to get a diagnosis and her success in finding her dream-come-true neurosurgeon.

A Mysterious Decline in Health

When Elisabeth N., 62, started developing symptoms that included obesity, osteoporosis, insomnia, kidney stones and hair loss, she attributed it to what most women her age would: menopause. Back in 2000 she never would have thought those seemingly normal symptoms for a woman her age would lead her to Santa Monica to be treated eight years later by Daniel Kelly, MD., neurosurgeon and director of the Pacific Pituitary Disorders Center at Pacific Neuroscience Institute and Saint John’s Health Center. In fact, it wasn’t till February of 2008 that she learned it could all be caused by something completely different.

A Sister’s Observation Leads to a Breakthrough

“I wouldn’t have known about Cushing’s disease if it weren’t for my youngest sister; I’m 25 years older and so fortunate she has her medical degree,” explained Elisabeth, a kitchen and bath designer in Mesa, Arizona. “We hadn’t seen one another for five years when we visited in February of 2008. My appearance had drastically changed by then. She told me, ‘Don’t be scared, Bethie, but I think you should be tested for Cushing’s.’”

Learning About Cushing’s Disease

cushing's disease symptoms infographic

Elisabeth started researching Cushing’s disease right away and was relieved to learn that a cure was possible. Cushing’s is a hormonal disorder caused by high levels of the hormone cortisol. Symptoms include upper-body obesity, fragile skin that bruises easily, weakened bones, severe fatigue, weak muscles, high blood pressure, high blood glucose, increased thirst and urination, depression and a fatty hump between the shoulders. Women can also experience irregular menstrual periods and excess hair growth on their bodies. It can be caused by taking glucocorticoids such as prednisone or if there is a problem with a person’s pituitary gland or hypothalamus.

A Long and Uncertain Testing Journey

Elisabeth immediately set up a doctor’s appointment to get her cortisol and adrenocorticotropic hormone (ACTH – the pituitary hormone that stimulates the adrenal glands to make cortisol) levels tested. Over the next nine months Elisabeth went through several blood, urine, saliva and plasma tests for her cortisol and ACTH production and had an MRI. The tests showed elevated cortisol and ACTH levels but the initial impression was that her levels were not high enough to indicate Cushing’s disease and her pituitary MRI showed no apparent tumor. Elisabeth met with both a pituitary neurosurgeon and an endocrinologist, but both determined her condition not to be Cushing’s.

“My cortisol was not high enough; I wasn’t obese enough; I wasn’t disabled enough; I wasn’t depressed enough,” Elisabeth said.

Finding the Missing Clue

She felt frustrated by the diagnosis and continued to research possibilities online. It was during this research that she stumbled upon an article comparing MRI Tesla strengths. It recommended getting a Tesla 3.0 with contrast to pick up small abnormalities. Elisabeth scheduled a new MRI at the beginning of November. This time the scan detected a 6 mm tumor on the right side of her pituitary gland. Additional hormonal testing also confirmed that she did indeed have high ACTH and cortisol levels consistent with Cushing’s, “I was thrilled to finally have proof I had Cushing’s, but terrified because I knew I’d have to have brain surgery to remove it,” Elisabeth said. “I knew I wanted transsphenoidal surgery – the safest, most successful procedure with the least complications if done by an experienced surgeon.”

Understanding the Endonasal Transsphenoidal Approach

endonasal procedure illustration

Endonasal transsphenoidal tumor removal, aka endoscopic endonasal approach, such as what Elisabeth needed, is a surgery that uses the nostril as the entry point with visualization from the operating microscope and endoscope. The approach passes through the back of the nasal cavity and into the sphenoid sinus to the skull base without facial incisions, brain retraction or post-operative nasal packing.

“This type of surgery is ideal for removing over 99% of pituitary adenomas, like what Elisabeth had and is considered first-line therapy for patients with Cushing’s disease,” Dr. Kelly explained. “Untreated or incompletely treated, Cushing’s disease is a very serious condition leading to uncontrolled hypertension, diabetes, weight gain and increased mortality.”

Choosing the Right Surgeon

With all the months she had to prepare for a diagnosis, Elisabeth knew exactly what needed to be done.

“I’d known I wanted Dr. Kelly to perform surgery but never imagined it could happen,” Elisabeth said. “I found him online. He’s ranked as one of the world’s top neurosurgeons specializing in this type of surgery. While watching his YouTube videos, I was awed by his kindness, patience, sense of humor, approachability, professionalism and complete lack of arrogance in spite of his fame. I’m still pinching myself that I had the fortune and honor to become one of his patients.”

A Life-Changing Call

Dr. Daniel Kelly and Dr. Chester Griffiths perform surgery

Figuring she didn’t have anything to lose, Elisabeth called Dr. Kelly’s office and asked if he was accepting new patients (he was) and how long was his waiting list (she could see him next week). Elisabeth was astounded. She immediately mailed Dr. Kelly all the test results, films and reports she could gather.

“Two days later, Dr. Kelly personally called and left a message, indicating it appeared there was indeed an ACTH secreting adenoma on my pituitary gland and to call him back,” Elisabeth said. “I was blown away. I’d have expected to win the lottery first.”

Successful Surgery and a New Beginning

Dr. Kelly arranged to perform Elisabeth’s surgery two weeks later on November 26 – the day before Thanksgiving. Her cortisol levels fell dramatically within 24 hours of surgery. She has remained in remission since then. Years after surgery, she continues to feel like a new person and regularly stays in contact with Dr. Kelly and his office staff.

About Dr. Daniel Kelly

Dr. Daniel Kelly, a board-certified neurosurgeon, is the director and one of the founders of the Pacific Neuroscience Institute, director of the Pacific Brain Tumor Center and Pacific Pituitary Disorders Center, and is Professor of Neurosurgery at Saint John’s Cancer Institute at Providence Saint John’s Health Center. Considered to be one of the top neurosurgeons in the US, he is a multiple recipient of the Patients’ Choice Award and Southern California Super Doctors distinction.

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