Drugs / Paltusotine
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed acromegaly 5 milestones | |||||
| Filed | Other | PALSONIFY | acromegaly | 2026-03-26 | “today announced the submission of a Marketing Authorization Application (MAA) to Brazil’s National Health Surveillance Agency (ANVISA) for PALSONIFY™ (paltusotine)” crinetics.com ↗ “In March 2026, Crinetics submitted a Marketing Authorization Application (MAA) to Brazil’s National Health Surveillance Agency (ANVISA) for PALSONIFY” crinetics.com ↗ |
| Filed | EU (EMA) | — | acromegaly | 2025-03-27 | “Marketing authorization application (MAA) validated by the European Medicines Agency (EMA) for paltusotine for the treatment of acromegaly” crinetics.com ↗ “the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for paltusotine” crinetics.com ↗ |
| Filed | US (FDA) | — | acromegaly | 2025-02-27 | “New Drug Application (NDA) for paltusotine for the treatment of acromegaly filed and accepted for review by U.S. Food and Drug Administration (FDA).” crinetics.com ↗ |
| Filed | US (FDA) | — | acromegaly | 2024-09-26 | “today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for paltusotine” crinetics.com ↗ “Submitted New Drug Application (NDA) for paltusotine for the treatment of acromegaly” crinetics.com ↗ |
| Filed | Japan (PMDA) | — | acromegaly | — | “In April 2026, SKK submitted a New Drug Application (NDA) in Japan for paltusotine for the treatment of acromegaly.” crinetics.com ↗ “SKK recently submitted a new drug application (NDA) in Japan for paltusotine for the treatment of acromegaly.” crinetics.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Palsonify | — | 2026-04-23 | europa.eu ↗ |
| Approved | US (FDA) | PALSONIFY | — | 2025-09-25 | fda.gov ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04246749 | Sep → Oct 2019 | — | Crinetics Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03276858 | Sep 2017 → Apr 2018 | — | Crinetics Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT05361668 | Apr 2022 → Mar 2024 | carcinoid syndrome, carcinoid tumor, pancreatic neuroendocrine tumor, small intestine neuroendocrine neoplasm | Crinetics Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04261712 | Jan 2020 → Mar 2028 expected | acromegaly | Crinetics Pharmaceuticals Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03789656 | Mar 2019 → Aug 2020 | acromegaly | Crinetics Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03792555 | Mar 2019 → Jul 2020 | acromegaly | Crinetics Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 33 trials · 2 met primary | ||||||
| Phase 3 | NCT07087054 | Nov 2025 → Aug 2027 expected | carcinoid syndrome, carcinoid tumor, intestinal neuroendocrine neoplasm | Crinetics Pharmaceuticals Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT05192382 | Dec 2021 → Jan 2024 | acromegaly | Crinetics Pharmaceuticals Inc. | Terminated | Met primary Stop: Business |
| Phase 3 | NCT04837040 | May 2021 → Jul 2023 | acromegaly | Crinetics Pharmaceuticals Inc. | Terminated | Met primary Stop: Business |
News releases announcing trial results or a regulatory action · 25
| Date | Issuer | Release |
|---|---|---|
| 2026-06-14 | Crinetics Pharmaceuticals Inc. | Results Crinetics Presents Long Term Data at ENDO 2026 Confirming PALSONIFY™ (paltusotine) Provides Durable, Consistent Acromegaly Control crinetics.com ↗
Data from up to two years of treatment in PATHFNDR-1 and PATHFNDR-2 open-label extension studies show PALSONIFY maintained lower IGF-1 levels and stable symptoms |
| 2026-04-27 | Crinetics Pharmaceuticals Inc. | Regulatory Crinetics Pharmaceuticals Announces the European Commission Approval of PALSONIFY® (Paltusotine) for the Treatment of Acromegaly in Adults crinetics.com ↗
Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today 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. |
| 2026-03-26 | Crinetics Pharmaceuticals Inc. | Regulatory Crinetics Pharmaceuticals Announces Submission of Marketing Authorization Application in Brazil for Palsonify™ (Paltusotine) in Acromegaly crinetics.com ↗ |
| 2025-10-23 | Crinetics Pharmaceuticals Inc. | Results Crinetics to Highlight Neuroendocrine Tumor Research Progress at the 2025 North American Neuroendocrine Tumor Society Annual Meeting crinetics.com ↗
Preliminary analysis of one-year progression-free survival data from Phase 2 study of novel SST2 agonist paltusotine under investigation for carcinoid syndrome demonstrated potential anti-tumor effects |
| 2025-09-25 | Crinetics Pharmaceuticals Inc. | Regulatory Crinetics Announces FDA Approval of PALSONIFY™ (paltusotine) for the Treatment of Acromegaly in Adults crinetics.com ↗
Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that the U.S. Food and Drug Administration (FDA) approved PALSONIFY™ (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. |
| 2025-07-13 | Crinetics Pharmaceuticals Inc. | Results Crinetics to Present New Long-Term Data Demonstrating Durable Control of Once-Daily, Oral PALSONIFY™ (Paltusotine) in Acromegaly at ENDO 2025 crinetics.com ↗
Data show that PALSONIFY was well tolerated and IGF-1 levels remained stably controlled during long-term open label extensions of PATHFNDR-1 and PATHFNDR-2 studies |
| 2025-05-15 | Crinetics Pharmaceuticals Inc. | Results Crinetics to Present New Research on Paltusotine, Atumelnant and Unmet Needs in Acromegaly Treatment at the American Association of Clinical Endocrinology Annual Meeting 2025 crinetics.com ↗
Post-hoc analysis from three clinical trials (PATHFNDR-1 [PF1], PATHFNDR-2 [PF2], and ACROBAT Advance) showed that paltusotine provided rapid and sustained insulin-like growth factor 1 (IGF-1) control in surgically naïve patients, including those who were biochemically uncontrolled at baseline. |
| 2025-03-27 | Crinetics Pharmaceuticals Inc. | Regulatory Crinetics Pharmaceuticals Announces European Medicines Agency (EMA) Validation of Marketing Authorization Application (MAA) and Orphan Drug Designation (ODD) for Paltusotine in Acromegaly crinetics.com ↗
The MAA will now be reviewed by the Committee for Medicinal Products for Human Use (CHMP). |
| 2024-12-09 | Crinetics Pharmaceuticals Inc. | Regulatory Crinetics Announces FDA Acceptance of New Drug Application for Paltusotine for Adult Patients with Acromegaly crinetics.com ↗
Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today 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. |
| 2024-09-26 | Crinetics Pharmaceuticals Inc. | Regulatory Crinetics Submits New Drug Application for Paltusotine for the Treatment of Acromegaly crinetics.com ↗ |
| 2024-06-03 | Crinetics Pharmaceuticals Inc. | Results Crinetics Presents New Data at ENDO 2024 that Increases that Increases Body of Evidence Positioning Once-Daily, Oral Paltusotine as Potential First-Choice Treatment Option for Acromegaly crinetics.com ↗
Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today presented findings from its clinical development program evaluating oral, once-daily investigational paltusotine in acromegaly. |
| 2024-03-19 | Crinetics Pharmaceuticals Inc. | Results Crinetics’ Once-Daily Oral Paltusotine Achieved the Primary and All Secondary Endpoints in the Phase 3 PATHFNDR-2 Study in Acromegaly Patients crinetics.com ↗
Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, today announced positive topline results from PATHFNDR-2, the second of two Phase 3 studies evaluating the efficacy and safety of oral, once-daily investigational paltusotine for the treatment of acromegaly. |
| 2024-03-12 | Crinetics Pharmaceuticals Inc. | Results Crinetics Announces Topline Results from Phase 2 Trial of Paltusotine for the Treatment of Carcinoid Syndrome crinetics.com ↗
Crinetics Announces Positive Topline Results from Phase 2 Trial of Paltusotine for the Treatment of Carcinoid Syndrome |
| 2023-12-18 | Crinetics Pharmaceuticals Inc. | Results Crinetics Announces Positive Initial Findings from Ongoing Open-Label Phase 2 Study of Paltusotine for the Treatment of Carcinoid Syndrome crinetics.com ↗
These initial results show the potential of paltusotine to significantly reduce both frequency and intensity of bowel movements and flushing, the key carcinoid syndrome symptoms. |
| 2023-09-10 | Crinetics Pharmaceuticals Inc. | Results Crinetics’ Once-Daily Oral Paltusotine Achieved the Primary and All Secondary Endpoints in the Phase 3 PATHFNDR-1 Study Evaluating Treatment of Patients with Acromegaly crinetics.com ↗
Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that paltusotine, an oral, once-daily investigational compound, achieved positive results by meeting the primary endpoint and all secondary endpoints of the Phase 3 PATHFNDR-1 study ( NCT04837040 ). |
| 2023-06-21 | Crinetics Pharmaceuticals Inc. | Results New Data Demonstrating Stable Biochemical and Symptom Levels with Two-Years of Oral Paltusotine Administration Presented at ENDO 2023 crinetics.com ↗
Approximately 90% of participants said they preferred once-daily, oral paltusotine over current standard of care of injected SRLs when asked after one year of treatment. |
| 2022-11-14 | Crinetics Pharmaceuticals Inc. | Results Crinetics Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Corporate Update crinetics.com ↗
Paltusotine lowered and maintained IGF-1 at levels comparable to prior injected SRL therapy for up to 103 weeks in participants living with acromegaly participating in the ACROBAT Advance Long-term Extension Study |
| 2022-09-06 | Crinetics Pharmaceuticals Inc. | Results New Long-Term Safety and Efficacy Data Presented with Paltusotine in Participants Living with Acromegaly crinetics.com ↗
These results show that paltusotine , an investigational compound, lowered and maintained insulin-like growth factor-1 (IGF-1) at levels comparable to prior injected SRL therapy for up to 103 weeks in participants living with acromegaly . |
| 2021-11-08 | Crinetics Pharmaceuticals Inc. | Results Crinetics Pharmaceuticals Presenting New Data from Open Label Extension Trial of Paltusotine in Acromegaly at the Society for Endocrinology BES Congress crinetics.com ↗
As of August 31, 2021, 23 of the 41 Advance participants had completed 51 weeks of treatment with only four participants discontinuing from the study. |
| 2021-03-22 | Crinetics Pharmaceuticals Inc. | Results Crinetics Pharmaceuticals Pipeline Progress on Display at ENDO 2021 crinetics.com ↗
As previously reported, after 13 weeks of treatment 20 of 23 participants who completed the dosing period maintained their IGF-1 to levels within 20% of their baseline or lower. |
| 2020-10-26 | Crinetics Pharmaceuticals Inc. | Results ACROBAT Edge Study of Paltusotine in Acromegaly Met Endpoint crinetics.com ↗
During the four-week washout period after the 13-week treatment period, Group 1 patients showed a meaningful (>20%) and prompt (within two weeks) rise in IGF-1 levels from baseline, which characterized the magnitude of therapeutic activity of oral paltusotine in acromegaly patients. |
| 2020-09-04 | Crinetics Pharmaceuticals Inc. | Results New Data from Paltusotine and ACTH Antagonist Development Programs- European Congress of Endocrinology crinetics.com ↗
A subsequent Phase 1 trial showed that paltusotine is 70% orally bioavailable. |
| 2020-07-08 | Crinetics Pharmaceuticals Inc. | Regulatory FDA Grants Crinetics Pharmaceuticals (CRNX) Orphan Drug Designation – Paltusotine for the Treatment of Acromegaly crinetics.com ↗
Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, today announced that the U.S. Food and Drug Administration (FDA) has granted paltusotine Orphan Drug Designation for the treatment of acromegaly. |
| 2020-04-06 | Crinetics Pharmaceuticals Inc. | Results Crinetics Pharmaceuticals Reports Positive Interim Results for the ACROBAT Edge Phase 2 Trial of Paltusotine (CRN00808) in Acromegaly Patients and Provides Corporate Update crinetics.com ↗
Results as of a February 23, 2020 data cutoff showed that acromegaly patients switching from injectable depot therapy to once daily oral paltusotine (formerly CRN00808) maintained IGF-1 levels previously achieved with commercially available depot injections of somatostatin receptor ligands (SRLs). |
| 2017-10-26 | Crinetics Pharmaceuticals Inc. | Regulatory Crinetics Pharmaceuticals Initiates Phase 1 Study of Lead Candidate CRN00808 for Acromegaly crinetics.com ↗ |
All press releases naming this drug 35 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | paltusotine | “Paltusotine, a novel oral once-daily nonpeptide SST2 receptor agonist, suppresses GH and IGF-1 in healthy volunteers.” PMID 35000098 ↗ Jan 2022 |
| Known as | CRN-00808 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL5267842 ↗ |
| Known as | CRN00808 | “paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist)” NCT04261712 ↗ |
| Known as | CRN00808.HCl | ChEMBL registry synonym — accepted as the source's own label CHEMBL5267842 ↗ |
| Known as | PALTUSOTINE HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL5267842 ↗ |
| Action | Activate | “somatostatin receptor subtype 2 (SST2) agonist” PMID 35000098 ↗ Jan 20221“Somatostatin receptor 2 agonist” CHEMBL5267842 ↗ |
| Modality | Small molecule | “orally bioavailable, nonpeptide” PMID 35000098 ↗ Jan 2022 |
| Route | Oral | “single-dose of oral paltusotine” PMID 35000098 ↗ Jan 2022 |
| Target | SSTR2 | “Somatostatin receptor 2 agonist” CHEMBL5267842 ↗ |