This section highlights FDA-related milestones and regulatory updates for drugs developed by Crinetics Pharmaceuticals (CRNX).
Over the past two years, Crinetics Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Atumelnant, CRN04894, Paltusotine, and TouCAHn. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Atumelnant - FDA Regulatory Timeline and Events
Atumelnant is a drug developed by Crinetics Pharmaceuticals for the following indication: In Congenital Adrenal Hyperplasia (CAH).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Atumelnant
- Announced Date:
- January 10, 2025
- Indication:
- In Congenital Adrenal Hyperplasia (CAH)
Announcement
Crinetics Pharmaceuticals, Inc. announced positive topline results from an open-label, Phase 2 congenital adrenal hyperplasia (CAH) study of investigational atumelnant, a novel, once-daily oral adrenocorticotropic hormone (ACTH) receptor antagonist candidate being developed for the treatment of classic CAH and ACTH-dependent Cushing's syndrome.
AI Summary
Crinetics Pharmaceuticals, Inc. announced positive topline results from its open-label, Phase 2 study of atumelnant. The investigational, once-daily oral adrenocorticotropic hormone (ACTH) receptor antagonist showed promising efficacy in treating congenital adrenal hyperplasia (CAH) and ACTH-dependent Cushing’s syndrome. In the study, atumelnant produced rapid, substantial, and sustained reductions in key biomarkers such as androstenedione and 17-hydroxyprogesterone over a 12-week treatment period. These decreases in biomarkers were coupled with notable improvements in clinical signs and symptoms of CAH, suggesting significant benefits to patient health. The encouraging safety and efficacy results have helped support Crinetics' plans to move forward with a global Phase 3 pivotal trial in adults, as well as new trials in pediatric patients. This development marks an important step in advancing atumelnant’s potential as a novel treatment option for patients with CAH and related conditions.
Read Announcement
CRN04894 - FDA Regulatory Timeline and Events
CRN04894 is a drug developed by Crinetics Pharmaceuticals for the following indication: Cushing's disease and Congenital Adrenal Hyperplasia (CAH).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CRN04894
- Announced Date:
- June 3, 2024
- Indication:
- Cushing's disease and Congenital Adrenal Hyperplasia (CAH)
Announcement
Crinetics Pharmaceuticals, Inc. announced initial findings from the development program of its second clinical product candidate, atumelnant* (CRN04894), a novel, once-daily oral adrenocorticotropic hormone (ACTH) receptor antagonist.
AI Summary
Crinetics Pharmaceuticals, Inc. announced initial findings from the development program of its second clinical product candidate, atumelnant (CRN04894). Atumelnant is a novel, once‐daily oral adrenocorticotropic hormone (ACTH) receptor antagonist, designed as a first-in-class treatment option. Early results from its Phase 2 clinical studies indicate promising efficacy and safety profiles, which could benefit patients with congenital adrenal hyperplasia and ACTH-dependent Cushing’s syndrome. This innovative approach offers the potential for a more convenient oral alternative to current therapies, which often rely on injections and have associated burdens. Crinetics’ work with atumelnant underscores its commitment to delivering novel, targeted treatments for challenging endocrine disorders through rigorous clinical evaluation and continued research.
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Paltusotine - FDA Regulatory Timeline and Events
Paltusotine is a drug developed by Crinetics Pharmaceuticals for the following indication: Acromegaly.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Paltusotine
- Announced Date:
- May 15, 2025
- Indication:
- Acromegaly
Announcement
Crinetics Pharmaceuticals, Inc. announced it will present two abstracts at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2025, taking place May 15–17 in Orlando, FL.
AI Summary
Crinetics Pharmaceuticals, Inc. announced that it will present two important abstracts at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2025, scheduled for May 15–17 in Orlando, FL. One abstract details a post-hoc analysis from three clinical trials involving their investigational drug paltusotine. The analysis shows that this once-daily oral drug provides rapid and long-lasting control of insulin-like growth factor 1 (IGF-1) levels in acromegaly patients who have not undergone surgery, with a good safety profile even in those who were previously uncontrolled.
The second abstract highlights the impact of acromegaly on daily life, documenting the burden of symptoms in patients treated with long-acting injectable therapies. Crinetics believes these presentations emphasize paltusotine’s potential to offer a more convenient and effective treatment option, which could significantly improve the standard of care for those living with acromegaly.
Read Announcement- Drug:
- Paltusotine
- Announced Date:
- March 27, 2025
- Indication:
- Acromegaly
Announcement
Crinetics Pharmaceuticals, Inc. announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for paltusotine, the first once-daily, oral, selectively-targeted somatostatin receptor type 2 nonpeptide agonist, for the proposed treatment and long-term maintenance therapy of acromegaly, a serious, rare and progressive endocrine disorder characterized by consistently elevated levels of growth hormone.
AI Summary
Crinetics Pharmaceuticals announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for paltusotine, a once-daily, oral, selectively targeted somatostatin receptor type 2 nonpeptide agonist. Paltusotine is designed for the treatment and long-term maintenance of acromegaly, a rare and progressive endocrine disorder that causes harmful levels of growth hormone. With this validation, the application will be reviewed by the Committee for Medicinal Products for Human Use (CHMP), marking an important regulatory milestone in Europe.
The EMA has also granted paltusotine Orphan Drug Designation, which underscores the drug’s potential to address an unmet need in acromegaly care. The MAA submission is supported by data from 18 clinical trials, including two Phase 3 studies that met both primary and secondary endpoints, demonstrating paltusotine’s safety and effectiveness for its proposed use.
Read Announcement- Drug:
- Paltusotine
- Announced Date:
- December 9, 2024
- Indication:
- Acromegaly
Announcement
Crinetics Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for investigational candidate paltusotine for the treatment and long-term maintenance therapy of acromegaly in adults.
AI Summary
Crinetics Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for paltusotine, an investigational candidate aimed at treating and maintaining long-term therapy for acromegaly in adults. If approved, paltusotine will be the first once-daily, oral, selective somatostatin receptor type 2 nonpeptide agonist available for acromegaly, offering a much-needed alternative to current injectable peptide therapies.
The NDA submission includes data from two Phase 3 trials, PATHFNDR-1 and PATHFNDR-2, which assessed safety and efficacy in both previously treated and untreated patients. This acceptance by the FDA, with a target review action date of September 25, 2025, marks a key milestone for Crinetics and its effort to improve treatment options for acromegaly, potentially transforming daily management of the disease for many adults.
Read Announcement- Drug:
- Paltusotine
- Announced Date:
- September 26, 2024
- Indication:
- Acromegaly
Announcement
Crinetics Pharmaceuticals, Inc. announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for paltusotine, the first once-daily, oral, selectively-targeted somatostatin receptor type 2 nonpeptide agonist in development for the proposed treatment and long-term maintenance therapy of acromegaly.
AI Summary
Crinetics Pharmaceuticals has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for paltusotine. This new drug is the first once-daily, oral, selectively-targeted somatostatin receptor type 2 nonpeptide agonist being developed for acromegaly. The submission marks a significant step toward providing a more convenient treatment option that could offer reliable long-term maintenance for patients. Based on data from 18 clinical trials, including two Phase 3 studies, paltusotine has demonstrated effective biochemical control and symptom relief for acromegaly patients, both those switching from monthly injections and those who had not received previous treatment. Crinetics plans to receive an update on the NDA status from the FDA in December, bringing hope to many affected by acromegaly.
Read Announcement- Drug:
- Paltusotine
- Announced Date:
- September 26, 2024
- Indication:
- Acromegaly
Announcement
Crinetics anticipates receiving notification from the FDA on the status of the NDA submission in December.
AI Summary
Crinetics Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for its promising treatment, paltusotine, which is designed for patients with acromegaly. The drug, taken once daily as an oral medication, has been tested in extensive Phase 3 studies that showed controlled hormone levels and improved symptom management in people with acromegaly. This condition, often caused by benign tumors in the pituitary gland, can lead to serious health issues if not properly managed.
Importantly, Crinetics anticipates receiving notification from the FDA regarding the status of the NDA submission in December. The company views this step as a crucial milestone in advancing a new generation of treatment options for acromegaly, potentially improving the quality of life for those affected. The submission highlights Crinetics’ commitment to developing innovative, patient-friendly therapies for endocrine disorders.
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TouCAHn - FDA Regulatory Timeline and Events
TouCAHn is a drug developed by Crinetics Pharmaceuticals for the following indication: In 21-hydroxylase deficiency.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TouCAHn
- Announced Date:
- January 10, 2025
- Indication:
- In 21-hydroxylase deficiency.
Announcement
Crinetics Pharmaceuticals, Inc. announced Highlights from the Phase 2 TouCAHn Trial
AI Summary
Crinetics Pharmaceuticals, Inc. reported positive topline results from its Phase 2 TouCAHn Trial. This open-label, global study enrolled 28 patients with congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency who were on stable glucocorticoid doses. The trial evaluated the efficacy and safety of atumelnant, a once-daily oral ACTH receptor antagonist designed to lower key disease biomarkers and improve clinical symptoms.
The study showed rapid, substantial, and sustained statistically significant reductions in androstenedione and 17-hydroxyprogesterone levels across all dose cohorts, with reductions of up to 80% at higher doses. Improvements included normalized testosterone in many female participants, a reduction in total adrenal volume, and resolution of androgen-mediated polycythemia. Atumelnant was well tolerated, and adverse events were mostly mild to moderate. These promising results support the initiation of Phase 3 trials for adult and pediatric patients with CAH.
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