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
Paltusotine, Atumelnant, CRN09682, and TouCAHn. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
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:
- April 27, 2026
- Indication:
- Acromegaly
Announcement
Crinetics Pharmaceuticals, Inc announced that the European Commission (EC) has approved PALSONIFY® (paltusotine), the first once-daily, oral, selectively-targeted somatostatin receptor type 2 nonpeptide agonist, for the treatment of adult patients with acromegaly.
AI Summary
Crinetics Pharmaceuticals announced that the European Commission has approved PALSONIFY (paltusotine), the first once-daily, oral, selectively-targeted somatostatin receptor type 2 nonpeptide agonist for treating adult patients with acromegaly. The approval was based on strong data from two pivotal Phase 3 studies that enrolled both medical-naïve and previously treated patients. This marks Crinetics’ first regulatory approval outside the U.S., with initial launches planned in Germany and Austria. The approval is valid across the 27 EU member states and three European Economic Area countries. The full European Summary of Product Characteristics will be available on the EMA website.
In trials, participants reported significant reductions in key acromegaly symptoms—such as headaches, joint pain, sweating, fatigue, weakness, swelling, and numbness—measured by the Acromegaly Symptom Diary. PALSONIFY was generally well tolerated, with no serious adverse events in the randomized controlled portion; the most common side effects were diarrhea, abdominal pain, nausea, and abdominal discomfort. Crinetics is preparing initial commercialization in Germany and Austria.
Read Announcement- Drug:
- Paltusotine
- Announced Date:
- November 20, 2025
- Indication:
- Acromegaly
Announcement
- Crinetics Pharmaceuticals, Inc. announced the first patient has been randomized in the pivotal Phase 3 CAREFNDR trial, a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of once-daily, oral paltusotine in adults with carcinoid syndrome due to well-differentiated neuroendocrine tumors.
AI Summary
Crinetics Pharmaceuticals announced the first patient has been randomized in the pivotal Phase 3 CAREFNDR trial, a multicenter, randomized, double-blind, placebo-controlled study testing once-daily oral paltusotine in adults with carcinoid syndrome from well-differentiated neuroendocrine tumors. The study follows positive Phase 2 results that showed quick, lasting reductions in flushing and bowel movement frequency.
CAREFNDR plans to enroll 141 adults, randomizing them 2:1 to paltusotine 80 mg or placebo. The primary endpoint is change in daily flushing episodes from baseline to Week 12; change in daily bowel movements is a key secondary endpoint. After a 16-week randomized period, participants can enter a 104-week open-label extension to assess long-term efficacy, safety and tumor control, including progression-free survival. Global enrollment is expected through 2025 and 2026, and the trial represents a step toward an oral treatment option aimed at reducing the burden of injectable therapies for patients with carcinoid syndrome.
Read Announcement- Drug:
- Paltusotine
- Announced Date:
- September 25, 2025
- Indication:
- Acromegaly
Announcement
Crinetics Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) approved PALSONIFYTM (paltusotine) 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.
AI Summary
Crinetics Pharmaceuticals announced FDA approval of PALSONIFY™ (paltusotine) as a first-line treatment for adults with acromegaly who did not respond to surgery or cannot undergo surgery. PALSONIFY is the first once-daily, oral therapy approved for this condition.
The approval relied on two pivotal Phase 3 trials where patients tolerated PALSONIFY well and achieved rapid and lasting control of growth hormone levels. They also reported significant relief from headaches, joint pain, fatigue, and sweating.
This oral option simplifies treatment compared to monthly injections and fulfills an unmet need for easy dosing and steady disease management. Crinetics expects PALSONIFY to be available in early October.
Crinetics will host an investor call at 6:00 pm ET today to discuss the approval. This launch marks a milestone as Crinetics strengthens its role as a leading global company focused on endocrine diseases.
Read Announcement- Drug:
- Paltusotine
- Announced Date:
- July 13, 2025
- Indication:
- Acromegaly
Announcement
Crinetics Pharmaceuticals, Inc. announced new data from its clinical development program evaluating once-daily, oral investigational PALSONIFYTM (paltusotine) in acromegaly will be presented in several oral and poster presentations at the Endocrine Society's Annual Meeting, ENDO 2025.
AI Summary
Crinetics Pharmaceuticals, Inc. announced that new data evaluating once-daily, oral investigational PALSONIFY™ (paltusotine) for acromegaly will be shared at ENDO 2025 during oral and poster presentations. The company will present long-term open-label extension findings from the pivotal PATHFNDR-1 and PATHFNDR-2 trials. In the PATHFNDR-1 extension study, individuals switching from monthly injectable somatostatin receptor ligands to PALSONIFY maintained stable IGF-1 and growth hormone levels alongside improved control of acromegaly symptoms. Similarly, the PATHFNDR-2 interim analysis showed that patients with biochemically uncontrolled acromegaly experienced significant reductions in IGF-1 levels and symptom burden. These presentations underscore PALSONIFY’s potential as a next-generation, convenient oral option, offering sustained biochemical control and symptom relief in acromegaly, while maintaining a consistent safety profile.
Read Announcement- 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.
Read Announcement
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 22, 2026
- Indication:
- In Congenital Adrenal Hyperplasia (CAH)
Announcement
Crinetics Pharmaceuticals, Inc. announced that the first patient has been dosed in the BALANCE-CAH Phase 2/3 trial evaluating investigational candidate atumelnant, a novel, once-daily oral adrenocorticotropic hormone (ACTH) receptor antagonist candidate for the proposed treatment of classic congenital adrenal hyperplasia (CAH) in children and adolescents.
AI Summary
Crinetics announced that the first patient has been dosed in BALANCE-CAH, a Phase 2/3 trial testing atumelnant, a novel once‑daily oral ACTH receptor antagonist, for the treatment of classic congenital adrenal hyperplasia (CAH) in children and adolescents. This marks the start of pediatric testing of the drug’s potential to address disease burden early in life.
Atumelnant is designed to block the melanocortin 2 receptor (MC2R) in the adrenal gland to prevent excess androgen production that drives many CAH complications. Earlier studies showed meaningful reductions in CAH biomarkers such as androstenedione (A4) and 17‑hydroxyprogesterone, suggesting the drug could control disease while allowing use of low glucocorticoid doses needed only for replacement.
The BALANCE-CAH study has three parts: Part A is a Phase 2 open‑label dose‑ranging phase, Part B is a Phase 3 double‑blind randomized placebo‑controlled confirmatory phase, and Part C is an open‑label extension. The trial will evaluate safety, efficacy, and pharmacokinetics in pediatric patients with significant unmet need.
Read Announcement- Drug:
- Atumelnant
- Announced Date:
- January 5, 2026
- Indication:
- In Congenital Adrenal Hyperplasia (CAH)
Announcement
Crinetics Pharmaceuticals, Inc. announced positive topline results from the fourth cohort of its 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 reported positive topline results from cohort 4 of its Phase 2 TouCAHn study of atumelnant, an investigational once-daily oral ACTH receptor (MC2R) antagonist. Cohort 4 enrolled 10 patients with classic CAH on stable glucocorticoid replacement; two withdrew and eight completed 12 weeks of atumelnant 80 mg. In those eight, mean morning androstenedione (A4) fell from 1,195 ng/dL by 866 ng/dL, a 67% reduction, and seven of eight maintained lower A4 after glucocorticoid doses were reduced. Overall, 88% of participants who completed 12 weeks successfully reduced glucocorticoid doses to physiologic replacement levels (<11 mg/m2/day hydrocortisone equivalent).
Atumelnant was well tolerated with no serious or severe treatment-related adverse events, no discontinuations for adverse events, and no hepatic transaminase elevations reported in cohort 4. An open-label extension snapshot showed similar A4 and glucocorticoid reductions in early enrollees. Across the CAH program, atumelnant has over 750 cumulative weeks of adult patient exposure and more than 200 participants exposed. The drug is in Phase 3 development and may offer a new oral treatment option for people with CAH and ACTH-dependent Cushing’s syndrome.
Read Announcement- Drug:
- Atumelnant
- Announced Date:
- January 4, 2026
- Indication:
- In Congenital Adrenal Hyperplasia (CAH)
Announcement
Crinetics Pharmaceuticals, Inc. announced that the company will host a conference call and webcast on Monday, January 5, 2026 at 8:30 a.m. ET to provide an update on PALSONIFY™ (paltusotine) commercialization and disclose topline results from the fourth cohort of the Phase 2 trial of atumelnant in congenital adrenal hyperplasia.
AI Summary
Crinetics Pharmaceuticals will host a conference call and webcast on Monday, January 5, 2026 at 8:30 a.m. ET to provide an update on PALSONIFY™ (paltusotine) commercialization and to disclose topline results from the fourth cohort of the Phase 2 trial of atumelnant in congenital adrenal hyperplasia (CAH). Company management will deliver prepared remarks followed by a live question-and-answer session.
The call will cover commercialization progress and next steps for PALSONIFY, and present initial top-line findings from the latest atumelnant cohort, which could inform the program’s development and planning for CAH. Investors and stakeholders can expect high-level context about business execution and clinical readouts.
Participants can join the live audio-only webcast on Crinetics’ website; an archived replay will be posted on the Events & Presentations page. To participate by phone, dial 1-833-470-1428 (U.S.) or 1-646-844-6383 (international) and use Access Code 640078.Read Announcement
- Drug:
- Atumelnant
- Announced Date:
- August 21, 2025
- Indication:
- In Congenital Adrenal Hyperplasia (CAH)
Announcement
Crinetics Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for atumelnant, a novel, once-daily oral adrenocorticotropic hormone (ACTH) receptor antagonist candidate for the proposed treatment of classic congenital adrenal hyperplasia (CAH).
AI Summary
Crinetics Pharmaceuticals announced the FDA granted Orphan Drug Designation for atumelnant, a novel once-daily oral ACTH receptor antagonist candidate targeting classic congenital adrenal hyperplasia (CAH). Atumelnant is the first small-molecule ACTH receptor blocker in clinical development.
Receiving the designation highlights the unmet need for CAH patients. Atumelnant aims to normalize adrenal androgen levels and lower glucocorticoid doses. Crinetics will test these effects and measure quality-of-life improvements in Phase 3 trials.
In January 2025, the Phase 2 TouCAHn trial showed robust, rapid, and sustained reductions in key biomarkers, including up to an 80% average decrease in androstenedione. Participants also saw clinical benefits such as resumed menstrual cycles and reduced adrenal size.
Crinetics plans to start CALM-CAH Phase 3 (adult) and BALANCE-CAH Phase 2/3 (pediatric) studies in late 2025. ODD provides fee waivers, financial incentives and seven years of U.S. market exclusivity.
Read Announcement- 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
CRN09682 FDA Regulatory Events
CRN09682 is a drug developed by Crinetics Pharmaceuticals for the following indication: Treatment of Neuroendocrine Tumors and Other Somatostatin Receptor 2-Expressing Tumors.
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:
- CRN09682
- Announced Date:
- December 3, 2025
- Indication:
- Treatment of Neuroendocrine Tumors and Other Somatostatin Receptor 2-Expressing Tumors
Announcement
Crinetics Pharmaceuticals, Inc. announced the first patient has been dosed in the Phase 1/2 study evaluating CRN09682 in patients with metastatic or locally advanced somatostatin receptor type 2 (SST2)-positive neuroendocrine tumors and other SST2-expressing solid tumors.
AI Summary
Crinetics Pharmaceuticals announced the first patient has been dosed in the Phase 1/2 BRAVESST2 trial of CRN09682, treating people with metastatic or locally advanced somatostatin receptor type 2 (SST2)-positive neuroendocrine tumors and other SST2-expressing solid tumors. CRN09682 is the lead candidate from Crinetics’ nonpeptide drug conjugate (NDC) platform.
CRN09682 is designed to bind SST2 on tumor cells, trigger receptor internalization, and release a potent cytotoxic payload (MMAE) inside the cancer cell via a cleavable linker. This targeted method aims to concentrate drug activity in tumors, improve tumor penetration, and reduce systemic exposure and related toxicities. The NDC approach uses traditional chemical synthesis.
The BRAVESST2 study is a first-in-human, open-label, dose-escalation trial with a planned dose-expansion phase to evaluate safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity. Phase 1 will find the maximum tolerated and recommended expansion doses, and Phase 2 will further assess selected SST2-expressing tumors. Up to 150 participants who progressed after standard therapies and have SST2 confirmed by imaging may enroll. Crinetics called dosing the first patient a major milestone for the program.
Read Announcement
TouCAHn FDA Regulatory 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.
Read Announcement
