Sepsis, a life-threatening condition due to a dysregulated response to infection, is the leading cause of global mortality and is frequently driven by tuberculosis (TB) and drug-resistant bacteria in sub-Saharan Africa, particularly among people living with HIV. The prevailing standard of care in the region, ceftriaxone alone, is insufficient as it does not address TB, drug-resistant bacteria, or adrenal insufficiency, which is common in HIV-related sepsis. Therefore, the investigators propose a randomized 2x2 factorial clinical trial to compare 28-day survival from sepsis between study participants who along with a standard of care that includes immediate conventional anti-TB treatment receive 1) hydrocortisone to treat septic shock and 2) rifampin, isoniazid, levofloxacin and linezolid to treat TB and other drug-resistant bacteria in order to deliver important and scalable knowledge that may alter the standard of care for sepsis in HIV endemic settings of sub-Saharan Africa. Improving understanding of the physiology and treatment alternatives for HIV related critical illness globally will have reciprocal benefit for health in the U.S.

Start Date01 Oct 2026

Sponsor / Collaborator

University of Virginia

[+1]

NCT07387926

/ Not yet recruitingPhase 1/2

Open-label, Phase I/II Study to Evaluate Safety and Efficacy of Asciminib With Chemotherapy Followed by Asciminib Plus Blinatumomab in Pediatric, Adolescent, and Young Adults With Relapsed or Refractory BCR::ABL1-positive (Philadelphia Positive, Ph+) or BCR::ABL1-like (Ph-like) ALL

Multi-center, open-label, single arm study of asciminib in participants aged ≥1 year to ≤30 years old with r/r Ph+ or ABL-class Ph-like ALL. This study will have 2 parts: Part 1 dose escalation and Part 2 dose expansion. Part 1 dose escalation will enroll participants aged ≥1 year to ≤30 years to determine the recommended phase 2 dose (RP2D) of asciminib when administered with low intensity chemotherapy. Part 2 dose expansion will enroll participants aged ≥1 year to ≤30 years to evaluate safety, tolerability, and efficacy of asciminib at the RP2D with the treatment regimen.

Start Date30 Jul 2026

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

NCT07612631

/ RecruitingEarly Phase 1IIT

Does a Hyperactive Nociceptin Opioid Peptide Receptor System Promote Relapse in Heavy Drinking AUD Subjects: a [C-11]NOP-1A and Hydrocortisone PET Study

This positron emission tomography imaging study uses [C-11]NOP-1A and hydrocortisone to image stress-modulating proteins in heavy drinking alcohol use disorder (AUD) subjects and healthy controls (HC). It will also characterize the role of these stress-regulating proteins in a relapse to alcohol.

Start Date01 Jun 2026

Sponsor / Collaborator

University of Pittsburgh

[+1]

100 Clinical Results associated with Hydrocortisone Acetate

100 Translational Medicine associated with Hydrocortisone Acetate

100 Patents (Medical) associated with Hydrocortisone Acetate

1,382

Literatures (Medical) associated with Hydrocortisone Acetate

02 Dec 2025·CURRENT MEDICAL RESEARCH AND OPINION

Observational pharmacy-based study provides real-world insights into the patient-perceived effectiveness and tolerability of a topically used hydrocortisone acetate in treating various allergic or mild inflammatory skin reactions

Article

Author: Tichi, Inga ; Roese, Nadine ; Rackelmann-Silber, Katrin

INTRODUCTION:

Topical hydrocortisones are commonly used for the self-treatment of allergic or mild inflammatory skin reactions. Post-market data analyzing usage, safety and effectiveness of hydrocortisone creams in a real-world setting are scarce.

METHODS:

This non-interventional, observational, pharmacy-based study analyzes the usage patterns and patient-perceived effectiveness and tolerability of Soventol Hydrocortisonacetat 0.5% (Soventol HCA) in a real-world setting. Adult participants with a moderately pronounced reddened, inflammatory or allergic skin disease for which a weak, low-concentration corticosteroid was indicated filled an online questionnaire parallel to product application for a maximum of 7 days. Severity of symptoms, frequency of application and the occurrence of adverse events were documented daily. The study was reported to the German Federal Institute for Drugs and Medical Devices (NIS-nr 7793).

RESULTS:

Data from 2,561 participants were received. Most participants used Soventol HCA for the treatment of insect bites (62.3%; N = 2,557). Almost all participants were "very satisfied" or "satisfied" with the effectiveness (97.7%; N = 2,106) and tolerability (99.1%; N = 2,106) of Soventol HCA. The vast majority of participants assessed the speed of itching relief (87.0%; N = 2,045), speed of cooling effect (90.5%; N = 2,073), pain relief (93.9%; N = 1,760), redness relief (90.2%; N = 2,033), and swelling relief (92.9%; N = 1,901) as "fast" to "very fast" or "good" to "very good." 61 non-serious adverse reactions were documented.

CONCLUSION:

This non-interventional study provides valuable real-world insights about the patient-perceived effectiveness and tolerability of Soventol HCA in treating insect bites, but also other inflammatory or allergic skin reactions as e.g. sunburn, allergies or eczema in adults. Patient satisfaction with effectiveness and tolerability was high in all application fields, especially regarding itch reduction of insect bites.

01 Dec 2025·Journal of Perinatology

Neurodevelopmental outcome in infants with neonatal encephalopathy receiving hydrocortisone during therapeutic hypothermia: follow-up of the extended-CORTISoL trial

Article

Author: Varga, Zsuzsanna ; McNamara, Patrick J ; Szabo, Attila J ; Meder, Unoke ; Szabo, Miklos ; Dobi, Marianna ; Kovacs, Kata ; Jermendy, Agnes ; Szakmar, Eniko

Abstract:

Objective:

To investigate neurodevelopmental outcome after hydrocortisone (HC) supplementation in infants with neonatal encephalopathy (NE) and hypotension.

Study design:

Fifty-five infants with volume-resistant hypotension during hypothermia were enrolled between 2016 and 2020. Eligible patients were randomly assigned to receive 0.5 mg/kg HC every 6 h or placebo along with standard dopamine treatment. Composite adverse outcome was defined as death or neurodevelopmental impairment, ascertained using the Bayley-II test.

Result:

At median 20 months of age, death, or severe neurodevelopmental impairment occurred in 40% in the HC group, compared to 18% in the placebo group ( p = 0.13). Multiple logistic regression analysis showed that for every 1 mg/kg increase in cumulative HC dose, the odds of adverse cognitive outcome increased by 16% (95% CI 1.01–1.37; p = 0.04).

Conclusion:

The composite outcomes were similar in the HC-treated and placebo groups, however cumulative HC dose was associated with adverse cognitive outcome in infants with NE and hypotension.

Clinical trial registration:

Hydrocortisone treatment in systemic low blood pressure during hypothermia in asphyxiated newborns (CORTISoL), ClinicalTrials.gov ID: NCT02700828 https://clinicaltrials.gov/ct2/show/NCT02700828 , date of registration: 2016-02-24.

01 Oct 2025·Drug Testing and Analysis

Endogenous Nature of Hydrocortisone Acetate in Horse

Article

Author: Wong, April S. Y. ; Ho, Emmie N. M. ; Kong, Fred K. W. ; Wan, Terence S. M.

ABSTRACT:

Hydrocortisone acetate, a synthetic acetate ester of hydrocortisone, was detected in horse blood samples collected from Thoroughbreds. Hydrocortisone acetate is generally considered an indicator for exogenous administration in horses. As hydrocortisone acetate has been previously reported to be endogenous in selected mammals, a proof‐of‐concept study was performed to evaluate the possible endogenous nature of hydrocortisone acetate in horses by in vitro incubation experiments using homogenized horse brain tissue.

News (Medical) associated with Hydrocortisone Acetate

02 Jun 2026

·www.biospace.com

Crinetics’ Paradigm-Shifting Portfolio and Pipeline on Display at ENDO 2026 with Six Presentations

Oral presentation features open label extension PALSONIFY™ (paltusotine) data, reinforcing its best-in-class potential in acromegaly following recent U.S. and E.U. approvals Two oral presentations of novel, investigational ACTH receptor antagonist atumelnant include full Phase 2 study results in congenital adrenal hyperplasia and data from additional patients in the Phase 1b/2a ACTH-dependent Cushing’s syndrome study SAN DIEGO, June 02, 2026 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that data from six abstracts, including oral presentations featuring PALSONIFY™ (paltusotine) and investigational candidate atumelnant, will be presented at the Endocrine Society’s Annual Meeting, ENDO 2026, June 13-16, 2026, in Chicago, IL. "At ENDO 2026, new data will be presented which increase the depth of clinical evidence supporting the long-term safety and efficacy of Palsonify for the treatment of acromegaly," said Dr. Alan Krasner, M.D., Chief Endocrinologist, Crinetics. “In addition, updated data will be presented characterizing the potential of atumelnant to set an uncompromising bar for treating diseases of ACTH excess. I have often been frustrated by the lack of optimized treatments for these and many other difficult to manage endocrine conditions. At Crinetics, we are continuously working with many outstanding external investigator colleagues to redefine the possibilities.” Three abstracts will report data related to PALSONIFY in acromegaly, including an oral presentation featuring long-term (up to two years) efficacy and pooled safety data from the PATHFNDR-1 and PATHFNDR-2 open-label extension (OLE) studies. Additionally, one poster presentation evaluates real-world biochemical control in acromegaly using U.S. claims and laboratory data to identify areas of unmet need for patients and to inform optimization of acromegaly management. Another poster presentation assesses long-term safety and efficacy of PALSONIFY in combination with cabergoline from the ACROBAT Advance trial. Three abstracts from Crinetics’ atumelnant clinical development program will also be presented, including oral presentations of full Phase 2 data in congenital adrenal hyperplasia (CAH) and new interim results from a Phase 1b/2a study in ACTH-dependent Cushing’s syndrome. An additional rapid-fire presentation highlights dose selection data for the Phase 3 trial in CAH. Crinetics will also present a product theater June 15 from 12:30-1:30 CST, titled “Advancing Acromegaly Management: Bridging Clinical Evidence and the Patient Journey with PALSONIFY™ (paltusotine). Presenters include Dr. Anthony Heaney and a patient living with acromegaly. Presentation details are shown below. PALSONIFY™ (paltusotine) Presentations Title (oral presentation): Efficacy and Safety of Once-Daily Oral Paltusotine in Patients with Acromegaly: Up to 2 years in the PATHFNDR-1 and PATHFNDR-2 Open-Label Extension Studies Authors: Gadelha, M.R. “et. al." Date/Time: June 14, 1:45 PM – 3:15 PM CT Location : Room W183BC Title (poster presentation): Long-Term Safety and Efficacy of Once-Daily Oral Paltusotine in Combination With Cabergoline for the Treatment of Patients With Acromegaly Authors: Gadelha. M.R. “et. al." Date/Time: June 14; 12:00 PM – 1:30 pm CT Location: ENDO Expo Hall, McCormick Place West Title (poster presentation) : Real-World Biochemical Control in Acromegaly: Insights from US Claims and Laboratory Data Authors: Wang, S “et. al." Date/Time: June 15; 12:00 PM – 1:30 pm CT Location: ENDO Expo Hall, McCormick Place West Atumelnant Presentations Title (oral presentation) : Once Daily Atumelnant (CRN04894) Enables Lowering of Glucocorticoid Doses With Sustained Androgen Reduction in Adults With Congenital Adrenal Hyperplasia Authors: Srirangalingam, U., “et. al." Date/Time: June 14, 1:45 PM – 3:15 PM CT Location: Room W184ABC Title (oral presentation): ‘Block And Replace’ Atumelnant (CRN04894) And Physiologic Hydrocortisone Replacement Rapidly Controls Hypercortisolism In ACTH-dependent Cushing Syndrome Authors: Elenius, H., “et al” Date/Time: June 14, 3:30 PM – 4:15 PM CT Location: Room W187 Title (rapid-fire and poster presentations) : Model-Informed Atumelnant Dose Selection for a Phase 3 Study in Adult Patients With Classic Congenital Adrenal Hyperplasia Authors: Curd, L., “et. al." Dates/Times: Rapid Fire: June 14, 1:45 PM - 3:15 PM CT Poster: June 15, 12:00 PM – 1:30 PM CT Locations: Rapid Fire: Room W184ABC Poster: ENDO Expo Hall, McCormick Place West About PALSONIFY™ (Paltusotine) PALSONIFY, a selectively-targeted somatostatin receptor type 2 (SST2) nonpeptide agonist, is the first and only once-daily, oral therapy approved for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. In Phase 3 studies, once-daily, oral PALSONIFY maintained IGF-1 levels and symptom control in patients with acromegaly who were switched from monthly injectable medications (PATHFNDR-1) and rapidly decreased IGF-1 levels and symptom burden in medically untreated acromegaly patients (PATHFNDR-2). IGF-1 is the primary biomarker endocrinologists use to manage acromegaly patients. Paltusotine is also in Phase 3 clinical development for carcinoid syndrome associated with neuroendocrine tumors (CAREFNDR). Results from a Phase 2 study in carcinoid syndrome demonstrated rapid and sustained reductions in flushing episodes and bowel movement frequency, which are the most common symptoms of carcinoid syndrome. PALSONIFY is approved in the U.S. for the first-line treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. It is also approved for use in the EU for the medical treatment of adult patients with acromegaly. About Atumelnant Atumelnant, Crinetics’ second investigational compound, is the first once-daily, oral adrenocorticotropic hormone (ACTH) receptor antagonist that acts selectively at the melanocortin type 2 receptor (MC2R) on the adrenal gland. Diseases associated with excess ACTH can have significant impact on physical and mental health. Atumelnant has exhibited strong binding affinity for MC2R in preclinical models and has demonstrated suppression of adrenally derived glucocorticoids and androgens that are under the control of ACTH. Data from a 12-week Phase 2 study demonstrated compelling treatment benefits of atumelnant, evidenced by the rapid, substantial and sustained statistically significant reductions in key CAH disease related biomarkers, including androstenedione and 17-hydroxyprogesterone, in a diverse population. Atumelnant is in development for congenital adrenal hyperplasia and ACTH-dependent Cushing’s syndrome, with the Phase 3 CALM-CAH trial and a Phase 1/2b trial in ADCS currently enrolling patients. About Crinetics Pharmaceuticals Crinetics Pharmaceuticals is a global pharmaceutical company committed to transforming the treatment of endocrine diseases and endocrine-related tumors through science rooted in patient needs. Crinetics is focused on discovering, developing, and commercializing novel therapies, with a core expertise in targeting G-protein coupled receptors (GPCRs) with small molecules that have specifically tailored pharmacology and properties. Crinetics’ first commercial product, PALSONIFY™ (paltusotine), is the first once-daily, oral treatment approved by the U.S. FDA and EMA for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. Paltusotine is also in clinical development for carcinoid syndrome associated with neuroendocrine tumors. Crinetics’ deep pipeline of 10+ disclosed programs includes late-stage investigational candidate atumelnant, which is currently in development for congenital adrenal hyperplasia and ACTH-dependent Cushing’s syndrome, and CRN09682, a nonpeptide drug conjugate candidate that is being developed to treat somatostatin receptor 2 (SST2) expressing neuroendocrine tumors and other SST2 expressing solid tumors. Additional discovery programs are focused on a variety of endocrine targets such as thyroid stimulating hormone (TSH), parathyroid hormone (PTH), somatostatin receptor 3 (SST3), growth hormone (GH), glucagon-like peptide-1 (GLP-1), and glucose-dependent insulinotropic polypeptide (GIP), as well as GPCR-targeted oncology indications. PALSONIFY™ (paltusotine) INDICATION: PALSONIFY is a somatostatin receptor agonist indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS: Cholelithiasis and Its Complications: Cholelithiasis, including related complications such as acute cholecystitis and pancreatitis, have been reported. Monitor patients periodically. Discontinue PALSONIFY if complications of cholelithiasis occur and treat appropriately. Hyperglycemia and Hypoglycemia: Hyperglycemia, diabetes mellitus, or hypoglycemia, may occur. Monitor blood glucose levels when PALSONIFY treatment is initiated or when dosage is altered. Adjust antidiabetic treatment accordingly. Cardiovascular Abnormalities: Cardiac conduction abnormalities and other ECG changes such as PR interval prolongation, bradycardia, sinus arrest, and atrioventricular block may occur in patients with acromegaly and were reported in PALSONIFY clinical trials. Dosage adjustments of concomitant drugs that have bradycardic effects may be necessary. Thyroid Function Abnormalities: Somatostatin analogs may suppress the secretion of thyroid-stimulating hormone, which may result in hypothyroidism. Periodic assessment of thyroid function is recommended. Steatorrhea and Malabsorption of Dietary Fats: Somatostatin analog treatment may result in malabsorption of dietary fats and subsequent symptoms of steatorrhea, loose stools, abdominal bloating, and weight loss. If new or worsening symptoms are reported with PALSONIFY, evaluate patients for potential pancreatic exocrine insufficiency and manage accordingly. Vitamin B12 Deficiency: Vitamin B12 deficiency may occur. Monitor vitamin B12 levels, if clinically indicated. ADVERSE REACTIONS: Most common adverse reactions (>5%) are diarrhea, abdominal pain, nausea, decreased appetite, sinus bradycardia, hyperglycemia, palpitations, and gastroenteritis. DRUG INTERACTIONS: Strong or Moderate CYP3A4 Inducers: may decrease PALSONIFY exposure. May require an increased dosage of PALSONIFY. Proton Pump Inhibitors: may decrease PALSONIFY exposure. May require an increased dosage of PALSONIFY. Avoid concomitant use of proton pump inhibitors in patients who are already on PALSONIFY 60 mg. Cyclosporine: may decrease cyclosporine exposure. May require cyclosporine dosage adjustment when used with PALSONIFY; follow therapeutic monitoring recommendations. Please report adverse events to Crinetics Pharmaceuticals at 1-833-CRN-INFO (1-833-276-4636) or FDA at 1-800-FDA-1088 or . Please see Full Prescribing Information including Patient Information . Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the plans and timelines for the clinical development of atumelnant and paltusotine for the treatment of carcinoid syndrome; or the potential for our development candidates to transition to clinical development. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” “upcoming” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including, without limitation, we may not be able to obtain, maintain and enforce our patents and other intellectual property rights, and it may be prohibitively difficult or costly to protect such rights; geopolitical events may disrupt Crinetics’ business and that of the third parties on which it depends, including delaying or otherwise disrupting clinical studies and preclinical studies, manufacturing and supply chain, or impairing employee productivity; unexpected adverse side effects, complications and/or drug interactions or inadequate efficacy of the Company’s product candidates that may limit their development, regulatory approval and/or commercialization; the Company’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; regulatory developments or political changes, including policies related to pricing and pharmaceutical drug reimbursement, in the United States and foreign countries; the timing and outcome of research, development and regulatory review is uncertain, and Crinetics’ drug candidates may not advance in development or be approved for marketing; Crinetics may use its capital resources sooner than expected or our cash burn rate may accelerate; any future impacts to our business resulting from geopolitical developments outside our control; and the other risks and uncertainties described in the Company’s periodic filings with the Securities and Exchange Commission (SEC). The events and circumstances reflected in the company’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Additional information on risks facing Crinetics can be found under the heading “Risk Factors” in Crinetics’ periodic filings with the SEC, including its annual report on Form 10-K for the year ended December 31, 2025. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by applicable law, Crinetics does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Media: Natalie Badillo Head of Corporate Communications nbadillo@crinetics.com (858) 345-6075 Investors: Gyathri Diwakar Head of Investor Relations gdiwakar@crinetics.com (858) 345-6340

Phase 2Clinical ResultPhase 3Drug Approval

06 May 2026

·www.biospace.com

Neurocrine Biosciences Announces Publication of Expert Recommendations for Glucocorticoid Dose Reduction after Initiating CRENESSITY® (crinecerfont) for the Treatment of Classic Congenital Adrenal Hyperplasia

New algorithms developed by expert clinical endocrinologists provide clear, practical recommendations for healthcare providers to reduce supraphysiologic glucocorticoid (GC) doses in patients with classic congenital adrenal hyperplasia (CAH) after starting CRENESSITY CRENESSITY reduces excess androgen production, enabling patients with classic CAH to move toward more physiologic GC dosing while maintaining essential daily cortisol replacement SAN DIEGO , May 6, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the publication of the first peer-reviewed expert recommendations to guide glucocorticoid dose reduction in patients with classic congenital adrenal hyperplasia treated with CRENESSITY ® (crinecerfont) . Published in The Journal of Clinical Endocrinology & Metabolism, the recommendations address a critical unmet need as real-world use of CRENESSITY expands in both pediatric and adult patients. The recommendations for clinicians treating classic congenital adrenal hyperplasia (CAH) patients with CRENESSITY are presented in two complementary manuscripts — one focused on pediatric patients aged four to 17 years and one focused on adults . The publications include the first structured, expert-driven algorithms for reducing supraphysiologic glucocorticoid (GC) dosing after initiating CRENESSITY in real-world clinical practice. CRENESSITY is approved as an adjunct treatment to GC replacement to control androgens in adult and pediatric patients four years of age and older with classic CAH. "By reducing ACTH and downstream androgen production, CRENESSITY allows patients with classic CAH, including both salt-wasting and simple virilizing forms, to move toward more physiologic, cortisol-replacing glucocorticoid dosing," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "Blocking excess ACTH and androgen production while maintaining necessary cortisol replacement reflects an important shift in how the disease is managed, helping to lower risks associated with long-term exposure to supraphysiologic glucocorticoid doses." In addition to the protocols used in the CAHtalyst ® Pediatric and Adult Phase 3 clinical trials, clinicians now have expert-developed systematic approaches to adjusting GC doses in pediatric and adult patients treated with CRENESSITY. These recommendations, grounded in both clinical trial and real-world clinical experience, recognize that treatment goals and clinical considerations differ meaningfully between children and adults and provide two distinct algorithms tailored to each population: Pediatric patients: The expert recommendations center on support to achieve normal growth and normalize bone age maturation and pubertal development while reducing long-term complications of excess GCs. GC reductions are targeted toward the upper portion of the physiologic range (8-11 mg/m 2 /day in hydrocortisone equivalents; full range 4-11 mg/m 2 /day) and are guided primarily by androgen concentrations, with close monitoring for GC withdrawal symptoms and adequate cortisol and mineralocorticoid replacement. Adult patients: The recommendations focus on minimizing GC-related metabolic, cardiovascular and skeletal complications while maintaining androgen control. GC reductions are targeted toward the physiologic range of 2-14 mg/m 2 /day in hydrocortisone equivalents and are paced according to current dose to manage any GC withdrawal symptoms and monitor for adequate cortisol replacement. "In children and adolescents with classic congenital adrenal hyperplasia, treatment decisions must carefully balance disease control with normal growth and development," said Mimi Kim, M.D., M.Sc., Associate Professor of Clinical Pediatrics, Keck School of Medicine, University of Southern California. "These recommendations provide clinicians with a structured, practical approach to glucocorticoid management that helps support growth, bone maturation and pubertal development as CRENESSITY is incorporated into care." "CRENESSITY enables us to decouple androgen control from the need for supraphysiologic glucocorticoids in patients with classic congenital adrenal hyperplasia," said Oksana Hamidi, D.O., M.S.C.S., Associate Professor of Internal Medicine, Division of Endocrinology, UT Southwestern Medical Center. "This new framework provides an algorithm and practical steps clinicians can take to lower glucocorticoid exposure without compromising cortisol replacement, helping to realize the benefits of this novel therapeutic approach in day-to-day care." GC reduction can offer important benefits for many patients and is therefore a common treatment goal with CRENESSITY. However, for some patients already taking a physiologic GC dose, CRENESSITY may be initiated to better manage androgens without increasing the GC dose. Key considerations outlined in both manuscripts include: Dose reductions should be gradual and clinically supervised , with ongoing assessment for symptoms of GC withdrawal, adrenal insufficiency and mineralocorticoid imbalance. Healthcare providers should consider monitoring key biomarkers , which may include androstenedione, 17-hydroxyprogesterone, adrenocorticotropic hormone (ACTH), testosterone and markers of mineralocorticoid status, such as renin and electrolytes. GC dose reduction is not a universal goal; for some patients, the focus is androgens. The expert recommendation highlights that some individuals may already be receiving a physiologic GC dose and may initiate treatment with CRENESSITY solely for androgen control. Dose reduction should be considered only when appropriate , including when androgens are at or below goal and when clinical goals support reducing supraphysiologic GC exposure. The publications and new clinical algorithms can be accessed here: 1 Glucocorticoid Reduction After Starting Crinecerfont in Pediatric Patients with Classic CAH: Practical Perspectives. 2 Glucocorticoid Reduction After Starting Crinecerfont in Adult Patients with Classic CAH: Practical Perspectives . * Figure reproduced from Nokoff NJ et al. J Clin Endocrinol Metab; 2026, 1 distributed under the terms of the Creative Commons CC BY license † Figure reproduced from Hamidi O, et al. J Clin Endocrinol Metab . 2026, 2 distributed under the terms of the Creative Commons CC BY license About Congenital Adrenal Hyperplasia Congenital adrenal hyperplasia (CAH) is a rare genetic condition that results in an enzyme deficiency that alters the production of adrenal steroid hormones, such as cortisol, aldosterone and adrenal androgens. Severe enzyme deficiency leads to an inability of the adrenal glands to produce enough cortisol and, in approximately 75% of cases, aldosterone. Because individuals with CAH are typically still able to produce androgens, the unused precursors that would normally be used to make cortisol instead result in the production of excess amounts of androgens. If left untreated, CAH can result in adrenal crisis and even death. Exogenous glucocorticoids (GCs) are necessary to correct the endogenous cortisol deficiency, but historically, doses higher than those needed for cortisol replacement (supraphysiologic) have been used to lower the elevated levels of adrenocorticotropic hormone (ACTH) and adrenal androgens. However, GC treatment at supraphysiologic doses has been associated with serious and significant complications of steroid excess, including metabolic issues such as weight gain and diabetes, cardiovascular disease and osteoporosis. Additionally, long-term treatment with supraphysiologic GCs may have psychological and cognitive impacts, such as changes in mood and memory. Adrenal androgen excess has been associated with abnormal bone growth and development in pediatric patients, female health problems such as excess facial hair growth and menstrual irregularities, in addition to cardiometabolic and fertility issues in both sexes. The symptoms of high ACTH may include testicular adrenal rest tumors (TARTs). About CRENESSITY ® (crinecerfont) CRENESSITY is a potent and selective oral corticotropin-releasing factor type 1 receptor (CRF 1 ) antagonist that reduces and controls excess adrenocorticotropic hormone (ACTH) and adrenal androgens through a non-glucocorticoid (GC) mechanism for the treatment of classic congenital adrenal hyperplasia (CAH). Antagonism of CRF 1 receptors in the pituitary has been shown to decrease ACTH levels, which in turn decreases the production of adrenal androgens and potentially the symptoms associated with CAH. The robust clinical study data demonstrate that lowering adrenal androgen levels with CRENESSITY enables lower, more physiologic dosing of GCs to replace missing cortisol. CRENESSITY comes in capsules and an oral solution. For adults 18 years of age and older, the recommended dosage is 100 mg twice daily taken orally with a meal. For pediatric patients four to 17 years of age weighing less than 55 kg (121 lbs), the recommended dosage is based on body weight and is administered twice daily, taken orally with a meal. For pediatric patients weighing more than 55 kg (121 lbs), the recommended dosage is 100 mg twice daily taken orally with a meal. Healthcare providers can work with patients to determine the appropriate formulation for use depending on patient needs. Patients receiving CRENESSITY should continue GC therapy for cortisol replacement. About The CAHtalyst ® Studies The Phase 3 CAHtalyst global registrational studies were designed to evaluate the safety, efficacy and tolerability of CRENESSITY ® (crinecerfont) in children and adults with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. The CAHtalyst studies were the largest-ever clinical trial program in classic CAH, including 285 pediatric and adult patients. The CAHtalyst Pediatric study included 103 pediatric patients four to 17 years of age. The study tested two questions. The first question evaluated whether four weeks of CRENESSITY treatment could improve androgen control. The second question evaluated whether an additional 24 weeks of CRENESSITY treatment enabled customized glucocorticoid (GC) down-titration while androstenedione levels were maintained or improved. The CAHtalyst Adult study included 182 adult patients 18 to 58 years of age. Similarly, the first question of the study evaluated whether four weeks of CRENESSITY treatment could improve androgen control, and the second question evaluated whether an additional 20 weeks of CRENESSITY treatment enabled GC reduction to physiologic range while androstenedione levels were maintained or improved. Data from the CAHtalyst Phase 3 studies supported approval of CRENESSITY by the U.S. Food and Drug Administration in December 2024. The open-label extension treatment portions of both studies are ongoing.  Important Information Approved Uses CRENESSITY ® (crinecerfont) is a prescription medicine used together with glucocorticoids (steroids) to control androgen (testosterone-like hormone) levels in adults and children 4 years of age and older with classic congenital adrenal hyperplasia (CAH). IMPORTANT SAFETY INFORMATION Do not take CRENESSITY if you: Are allergic to crinecerfont, or any of the ingredients in CRENESSITY. CRENESSITY may cause serious side effects, including: Allergic reactions. Symptoms of an allergic reaction include tightness of the throat, trouble breathing or swallowing, swelling of the lips, tongue, or face, and rash. If you have an allergic reaction to CRENESSITY, get emergency medical help right away and stop taking CRENESSITY. Risk of Sudden Adrenal Insufficiency or Adrenal Crisis with Too Little Glucocorticoid (Steroid) Medicine. Sudden adrenal insufficiency or adrenal crisis can happen in people with congenital adrenal hyperplasia who are not taking enough glucocorticoid (steroid) medicine. You should continue taking your glucocorticoid (steroid) medicine during treatment with CRENESSITY. Certain conditions such as infection, severe injury, or shock may increase your risk for sudden adrenal insufficiency or adrenal crisis. Tell your healthcare provider if you get a severe injury, infection, illness, or have planned surgery during treatment. Your healthcare provider may need to change your dose of glucocorticoid (steroid) medicine. Before taking CRENESSITY, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. The most common side effects of CRENESSITY in adults include tiredness, headache, dizziness, joint pain, back pain, decreased appetite, and muscle pain. The most common side effects of CRENESSITY in children include headache, stomach pain, tiredness, nasal congestion, and nosebleeds. These are not all the possible side effects of CRENESSITY. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at  or call 1-800-FDA-1088. Dosage Forms and Strengths: CRENESSITY is available in 50 mg and 100 mg capsules, and as an oral solution of 50 mg/mL. Please see full Prescribing Information . About Neurocrine Biosciences, Inc. Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine, psychiatric and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com , and follow the company on LinkedIn , X , Facebook and YouTube . (*in collaboration with AbbVie ) The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, CRENESSITY and CAHtalyst are registered trademarks of Neurocrine Biosciences, Inc. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from CRENESSITY for the treatment of classic congenital adrenal hyperplasia (CAH); the value and benefits CRENESSITY brings to patients with CAH, including its potential to enable patients to transition toward more physiologic glucocorticoid dosing; the clinical utility, adoption and impact of the newly published expert recommendations and algorithms for glucocorticoid dose reduction in pediatric and adult patients treated with CRENESSITY; the ability of Neurocrine Biosciences to ensure patients have access to CRENESSITY; and whether the results from our clinical trials of CRENESSITY are indicative of real-world results. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of CRENESSITY, including the extent to which patients and physicians accept and adopt CRENESSITY; whether CRENESSITY receives adequate reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for CRENESSITY; risks associated with the Company's dependence on third parties for development and manufacturing activities related to CRENESSITY, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for CRENESSITY may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding CRENESSITY; risks that post-approval CRENESSITY commitments or requirements may be delayed; risks that CRENESSITY may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks and uncertainties relating to competitive products and technological changes that may limit demand for CRENESSITY; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended March 31, 2026. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law. © 2026 Neurocrine Biosciences, Inc. All Rights Reserved. CAP-CFT-US-0047 05/2026 View original content to download multimedia: SOURCE Neurocrine Biosciences, Inc.

Phase 3Clinical Result

06 May 2026

·www.biospace.com

Cristcot Appoints Rayna Herman as President of its Hydrocortisone Acetate Commercial Division

Ms. Herman is a life sciences executive with extensive experience developing commercialization strategies and building commercial teams AUSTIN, Texas, May 06, 2026 (GLOBE NEWSWIRE) -- Cristcot, a clinical-stage pharmaceutical company advancing targeted therapies for gastrointestinal diseases, today announced the appointment of Rayna Sethi Herman as President of the Company’s hydrocortisone acetate (HCA) commercial division. Ms. Herman will focus on launch execution and strategy for the Company’s patented next-generation hydrocortisone acetate (ngHCA) 90-milligram suppository currently under review by the U.S. Food and Drug Administration (FDA) administered using Cristcot’s patented, FDA-cleared Sephure ® suppository applicator. “We are pleased to welcome Rayna to the Cristcot team. She is an effective cross-functional leader with a proven track record building and scaling commercial operations, including integration to the broader business infrastructure. Her ability to deliver revenue and market share results will be invaluable as we prepare for the launch of ngHCA, once approved,” said Jennifer J. Davagian, Cristcot Founder and Chief Executive Officer. “I am honored to join the Cristcot leadership team at such a pivotal time,” said Ms. Herman. “I am excited for the opportunity to ensure readiness for the launch of ngHCA, as well as Cristcot’s future pipeline of investigational programs.” Rayna Herman joins Cristcot from Shorla Oncology, where she served as Chief Commercial Officer, building its U.S. commercial infrastructure from the ground up. Her responsibilities included determining which capabilities to build internally vs. leveraging outsourced solutions, leading vendor selection/RFP processes, and securing all specialty distribution agreements. In that role, she developed commercialization strategies and launched three branded products and one generic product delivering remarkable revenue growth in 2025 in a highly competitive market. Ms. Herman previously served as Chief Commercial Officer, Complete Commercialization, at EVERSANA, where she developed strategy, led commercial teams, and launched pharmaceutical products through EVERSANA’s Complete Commercialization Program. She began her career in sales and marketing at Merck. Ms. Herman holds a Master of Business Administration from the John M. Olin School of Business at Washington University, St. Louis, Missouri, and a Bachelor of Arts in Chemistry from Indiana University, Bloomington, Indiana. About ngHCA ngHCA, Cristcot’s investigational hydrocortisone acetate (HCA) 90 mg suppository formulation, is a novel corticosteroid therapy delivering a small volume suppository administered using the Sephure ® suppository applicator. Rectally administered topical treatments, including topical corticosteroids, are important treatment options (either alone or in combination with other therapies), for directing delivery to inflammation sites and limiting systemic drug exposure. Unlike other corticosteroid treatments, Cristcot's advanced HCA formulation allows for rapid, sustained release with optimal bioavailability, and very limited systemic exposure. Cristcot’s innovative delivery system is designed to overcome the treatment barriers associated with currently available therapies and enhance patient compliance. If approved by FDA, ngHCA would be the first and only FDA-approved HCA suppository. About Ulcerative Colitis (UC) UC is a life-long, chronic gastrointestinal autoimmune disease characterized by inflammation and ulcers in the lining of the large intestine, including the rectum and sometimes, all or part of the colon. Symptoms include rectal bleeding, profuse diarrhea, bowel urgency, tenesmus, and abdominal pain significantly impacting patients' quality of life. UC flares originate in the rectum, and if left untreated, inflammation can progress to more proximal disease and severity, leading to hospitalization or surgery. There is no cure for UC, and breakthrough flares, even while taking maintenance medication, is a known pattern of the disease profile. Over 80% of UC patients experience two flares annually, with many reporting debilitating effects on daily activities, work, and mental health. Despite existing treatments, patients experience intermittent flares and often change therapies as a measure to treat increased disease activity. The time of transition between one treatment to another is further complicated while waiting for the new therapy to reach full efficacy potential. About Cristcot Cristcot is a clinical-stage pharmaceutical company dedicated to advancing targeted therapies for gastrointestinal diseases. The Company's lead asset, ngHCA, is positioned to become an important therapeutic option for ulcerative colitis patients. Cristcot's diversified pipeline includes investigational development programs for ulcerative colitis, acute pancreatitis, hemorrhoid disease and other inflammatory gastrointestinal indications with an emphasis on innovative, patient-centric solutions. The company is headquartered in Austin, Texas. For more information, please contact us via email or connect with us on LinkedIn. Forward-Looking Statements Certain information set forth in this press release contains "forward-looking information", including "future-oriented financial information" and "financial outlook", under applicable securities laws (collectively referred to herein as forward-looking statements). Examples of forward-looking statements include, but are not limited to, statements regarding the (i) projected financial performance of the Company; (ii) market prospects and potential future sales for the Company products; (iii) expected development of the Company's products, business and projects; (iv) availability of competing products in the market; (v) prospects for regulatory approval of the Company's products; (vi) execution of the Company's vision and growth strategy; and (vii) availability of protections under applicable intellectual property laws. These statements are not guarantees of future performance, and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements. Although forward-looking statements contained in this press release are based upon what management of the Company believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The Company undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements. Contacts Jenny Gizzi, Chief Administrative Officer Cristcot E: jenny.gizzi@cristcot.com Investor Relations Lisa M. Wilson T: 212-452-2793 E: lwilson@insitecony.com

Executive ChangeDrug Approval

100 Deals associated with Hydrocortisone Acetate

External Link

KEGG	Wiki	ATC	Drug Bank
D00165	-	-	DB14539

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Dermatitis	Australia	Aspen Pharmacare Australia Pty Ltd.	14 Oct 1991
Eczema	Australia	Aspen Pharmacare Australia Pty Ltd.	14 Oct 1991
Ulcerative proctitis	United States	Mylan Specialty LP	10 Feb 1982
Colitis, Ulcerative	United States	Merck & Co., Inc.	21 Dec 1951
Skin Diseases	United States	Merck & Co., Inc.	21 Dec 1951

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AAD2026	Not Applicable	Lichen Planus	1,417	Systemic corticosteroids	dkazyesdlx(yrrntwylbv) = lfimmdwdke zswwoaqluy (efrmeextez )	Positive	27 Mar 2026
				Tildrakizumab	dkazyesdlx(yrrntwylbv) = hxmnicramn zswwoaqluy (efrmeextez )
NCT02700828 (CORTISoL, Pubmed \| J Perinatol)	Phase 2/3	Neonatal encephalopathy	55	Hydrocortisone	soqpdmmwzb(pejmfrnybr): P-Value = 0.13	Negative	01 Dec 2025
				Placebo
NCT00136435 (CTgov)	Phase 2	Acute Lymphoblastic Leukemia	100	L-asparaginase	sfxfshhlky = kdxjtrcwdo ftwoqcsoeq (ayvxpumeif, xrhqoxqhwn - zrkqwhgvjf) View more	-	20 Oct 2025
NCT03718234 (CTgov)	Phase 1	Adrenal Hyperplasia, Congenital \| Adrenocortical Hyperfunction \| Hyperplasia	11	Subcutaneous hydrocortisone	vkzgznnagz(relxdhdxgv) = bcprmdqlts kgrehvghxw (vqracgljku, 9.96) View more	-	25 Jun 2025
NCT00623740 (EudraCT number 2007-002041-20, Pubmed \| Eur J Pediatr)	Phase 3	Obstetric Labor, Premature	-	Prophylactic hydrocortisone	izcfqilwxu(emknbuerch) = acrrlammzw ecwkzkqvsr (whqnxolpmy )	Negative	14 Jun 2025
				Placebo	izcfqilwxu(emknbuerch) = qxcxacddfj ecwkzkqvsr (whqnxolpmy )
NCT00001521 (CTgov)	Phase 3	Adrenal Hyperplasia, Congenital \| Congenital Adrenal Hyperplasia Due to 21 Hydroxylase Deficiency	66	Fludrocortisone+Letrozole+Testolactone+Flutamide+Hydrocortisone (Investigational Therapy)	whrvkrtjii(dvvwehforh) = affabzcqni jsjrbkaobu (oudwkbblkj, 0.93) View more	-	12 Jun 2025
				Fludrocortisone+Hydrocortisone (Standard Therapy)	whrvkrtjii(dvvwehforh) = pqppwrwqdm jsjrbkaobu (oudwkbblkj, 0.89) View more
cessa (PRNewswire) Manual	Phase 3	Ulcerative proctitis	171	Hydrocortisone Acetate Suppository 90mg QDHydrocortisone Acetate Suppository 90mg QD	wqiuhttsnt(zcutzcqzpv) = vdjyjqrbea gnmqmlrbfu (avzzmjyfhw ) Met	Positive	09 Jan 2025
				Hydrocortisone Acetate Suppository 90mg BIDHydrocortisone Acetate Suppository 90mg BID	wqiuhttsnt(zcutzcqzpv) = dwnjfemuuw gnmqmlrbfu (avzzmjyfhw ) Met
NCT03062280 (CTgov)	Phase 3	Adrenal Hyperplasia, Congenital	91	Hydrocortisone	bckhmilzlq = lcwcpndlnm jyeowexzzg (kogahslkox, glwqyjcqft - tsikpvlzgs) View more	-	24 Oct 2024
NCT03792256 (CTgov)	Phase 1	Recurrent Adult Acute Lymphoblastic Leukemia \| T-Cell Lymphoma \| acute leukemia ... View more	12	ARAC (Stratum 1 With 50 mg/m^2)	czcjtzimnv = giglwlspxa hhsdbmefac (hxjommdzlv, fdyjbcqxbd - qgbkejmjkj) View more	-	16 Aug 2024
				ARAC (Stratum PK With 50 mg/m^2)	czcjtzimnv = egbgtsqpwu hhsdbmefac (hxjommdzlv, urfkugvzmv - weykaaievp) View more
NCT00859781 (CTgov)	Phase 2	Non-metastatic prostate cancer	55	111In-J591+Ketoconazole+Hydrocortisone	bgxptxahxp = ayuorpdhko oudvsucmny (hrvofjfydz, hmnkfioxsd - ztokfhszot) View more	-	19 Jul 2023

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