paltusotine (CRN00808) / Crinetics - LARVOL DELTA

New treatments for acromegaly: Is a revolution underway? (PubMed, Ann Endocrinol (Paris)) - "We report results for new compounds that may be used in the near future as alternatives to first-generation somatostatin receptor ligands, with data on efficacy and tolerance: oral octreotide, paltusotine and long-acting subcutaneous octreotide are reviewed in detail, together with potential new compounds under investigation. We also discuss their potential role in the therapeutic armamentarium for acromegaly."

Journal • Acromegaly • Endocrine Disorders • SSTR

Are Oral Somatostatin Receptor Ligands Moving Closer to Becoming a Reality? (PubMed, Clin Endocrinol (Oxf)) - "The iSRLs require intramuscular or deep subcutaneous injection with a wide bore needle that can be complicated by injection site pain, erythema, subcutaneous nodule formation, and for most individuals require attendance with a healthcare professional every 28 days to safely administered the medication. Two oral SRL (oSRL) formulations, Oral Octreotide Capsules and Paltusotine have been developed with clinical studies showing them to have promise as a therapeutic alternative to iSRL."

Journal • Acromegaly • Dermatology • Endocrine Disorders • Pain • IGF1 • SSTR

Crinetics Announces FDA Acceptance of New Drug Application for Paltusotine for Adult Patients with Acromegaly (GlobeNewswire) - "FDA Assigns a Prescription Drug User Fee Act Target Action Date of September 25, 2025...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....The NDA submission for once-daily, oral paltusotine included data from the PATHFNDR-1 (NCT04837040) and PATHFNDR-2 (NCT05192382) Phase 3 clinical trials..."

FDA filing • PDUFA • Acromegaly

Advances in the Oral Administration of Somatostatin Receptor Ligands in Acromegaly: A Systematic Review Focusing on Biochemical Response. (PubMed, Pharmaceutics) - "While long-term maintenance was confirmed for OOCs, no data are yet available for paltusotine. Several gaps remain, such as the need for head-to-head comparisons between OOCs and paltusotine, and clinical trials in patients who have not received prior injectable SRL treatment."

Journal • Review • Acromegaly • Endocrine Disorders • Gastrointestinal Disorder • SSTR

Paltusotine May Address Unmet Need in NETs Patients With Carcinoid Syndrome (Cancer Therapy Advisor) - "Paltusotine can alleviate symptoms of carcinoid syndrome in patients with neuroendocrine tumors (NETs), according to results of a phase 2 study presented at the 2024 NANETS Multidisciplinary NET Medical Symposium....These findings suggest that paltusotine may address unmet needs in patients with carcinoid syndrome, according to study presenter by Aman Chauhan, MD..."

Media quote

"Paltusotine and CRN09682: Novel NonPeptide Approaches to Treating Carcinoid Syndrome and Neuroendocrine Tumors" (NANETS 2024) - "sponsored by Crinetics."

Carcinoid Syndrome • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

Once-daily Oral Paltusotine in the Treatment of Patients With Carcinoid Syndrome: Results From a Phase 2, Randomized, Parallel-Group Study (NANETS 2024) - "No new safety signals were identified. CONCLUSIONS In this phase 2 study, treatment with once-daily, oral paltusotine reduced the frequency and severity of CS symptoms and was well tolerated, justifying further clinical development."

Clinical • P2 data • Acromegaly • Carcinoid Syndrome • CNS Disorders • Neuroendocrine Tumor • Pain • SSTR

UPDATE: Crinetics Pharmaceuticals to Showcase Pipeline Advancements with Neuroendocrine Tumor Candidates at The North American Neuroendocrine Tumor Society (NANETS) Annual Meeting (GlobeNewswire) - "Data for paltusotine and CRN09682, along with additional information on NDCs, will also be featured in a Crinetics-sponsored symposium titled 'Paltusotine and CRN09682: Novel Nonpeptide Approaches to Treating Carcinoid Syndrome and Neuroendocrine Tumors' at the conference...Dr. Aman Chauhan..."

Crinetics Pharmaceuticals to Showcase Pipeline Advancements with Neuroendocrine Tumor Candidates at The North American Neuroendocrine Tumor Society (NANETS) Annual Meeting (GlobeNewswire) - "Preclinical data to be presented at NANETS 2024 demonstrate the potent and selective anti-tumor activity of CRN09682, potentially providing a novel alternative for the treatment of NETs and other SST2-expressing tumors. Another abstract will be featured as both an oral and poster presentation, which includes follow-up from an open-label Phase 2 carcinoid syndrome study of investigational candidate paltusotine, a once-daily, oral, nonpeptide, selective SST2 agonist being developed for the treatment of acromegaly and carcinoid syndrome. The NANETS presentation includes findings from all 36 trial participants, with new analyses that show paltusotine reduced the frequency and severity of carcinoid syndrome symptoms and was well tolerated, justifying further clinical development."

P2 data • Preclinical • Carcinoid Syndrome • Neuroendocrine Tumor • Oncology • Solid Tumor

UPDATE: Crinetics Pharmaceuticals to Showcase Pipeline Advancements with Neuroendocrine Tumor Candidates at The North American Neuroendocrine Tumor Society (NANETS) Annual Meeting (GlobeNewswire) - "..."We will also present data from the Phase 2 clinical study of our investigational drug candidate paltusotine, highlighting its ability to reduce the frequency and severity of carcinoid syndrome symptoms in patients with functional NETs'....Abstract will be featured as both an oral and poster presentation, which includes follow-up from an open-label Phase 2 carcinoid syndrome study of investigational candidate paltusotine, a once-daily, oral, nonpeptide....The NANETS presentation includes findings from all 36 trial participants, with new analyses that show paltusotine reduced the frequency and severity of carcinoid syndrome symptoms and was well tolerated, justifying further clinical development."

P2 data • Carcinoid Syndrome • Neuroendocrine Tumor

The current status of somatostatin analogs in the treatment of neuroendocrine tumors and future perspectives. (PubMed, Expert Rev Neurother) - "Perspectives on emerging nonpeptide SSAs such as paltusotine and innovative formulations of octreotide (CAM2029) are included. Octreotide and lanreotide appear to be clinically interchangeable, and no signs of superiority of one agent over the other has been observed so far. Whether SSAs may be exploited in the maintenance setting following more aggressive treatments, whether continuing SSAs beyond-progression after first-line therapy could be an effective treatment strategy, and whether new-generation SSAs such as pasireotide could overcome resistance to established SSAs are key areas of investigation."

Journal • Review • Carcinoid Tumor • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

Paltusotine: A Step Towards Precision Medicine in Acromegaly. (PubMed, J Clin Endocrinol Metab) - No abstract available

Journal • Acromegaly • Endocrine Disorders

Treatment of acromegaly with the nonpeptide, highly selective somatostatin receptor type 2 agonist paltusotine. (PubMed, Best Pract Res Clin Endocrinol Metab) - "To date, phase 2 and 3 clinical trials suggest paltusotine treatment can achieve biochemical and symptom control in acromegaly, with a safety profile comparable to those of the fg-SRLs. Since paltusotine is a once-daily oral drug, it may represent a future treatment option for addressing patient preference or improving quality of life."

Journal • Review • Acromegaly • Endocrine Disorders • Pain • SSTR • SSTR2

Acromegaly Disease Control Maintained After Switching From Injected Somatostatin Receptor Ligands to Oral Paltusotine. (PubMed, J Clin Endocrinol Metab) - "Replacement of injected SRLs by once-daily oral paltusotine was effective in maintaining both biochemical and symptom control in patients with acromegaly and was well tolerated."

Clinical • Journal • Acromegaly • Endocrine Disorders • Gastrointestinal Disorder • IGF1 • SSTR • SSTR2

Paltusotine: A Novel, Investigational Oral Small Molecule Somatostatin Receptor Ligand for Acromegaly by Crinetics (AACE 2024) - "Results from the PATHFNDR-1 Phase 3 study in patients with acromegaly switched from injected SRL monotherapy to once-daily oral paltusotine will be presented. Paltusotine is an investigational drug and has not yet been filed or approved for marketing authorization."

Acromegaly • Endocrine Disorders • Pain • Pituitary Gland Carcinoma • IGF1 • SSTR

Oral Octreotide Capsules and Paltusotine in Management of Acromegaly. (PubMed, touchREV Endocrinol) - "Adverse events with both OOC and paltusotine were reflective of those recognized with iSRL and occurred at a similar frequency. OOC and paltusotine are well-received additions to the therapeutic armamentarium in medical therapy for the management of acromegaly; however, further data on efficacy, tumour control and shrinkage are required to allow positioning of this medication within the management algorithm for acromegaly."

Journal • Review • Acromegaly • Dermatology • Endocrine Disorders • Oncology • IGF1 • SSTR

Efficacy And Safety Of Once-daily Oral Paltusotine In Medically Untreated Patients With Acromegaly: Results From The Phase 3, Randomized, Placebo-controlled Pathfndr-2 Study (ENDO 2024) - "Abstract is embargoed at this time."

Clinical • Late-breaking abstract • P3 data • Acromegaly • Endocrine Disorders

Long-term Safety And Efficacy Of Once-daily Oral Paltusotine In The Treatment Of Patients With Acromegaly: Update From Acrobat Advance (ENDO 2024) - "Abstract is embargoed at this time."

Clinical • Late-breaking abstract • Acromegaly • Endocrine Disorders

Use of the Acromegaly Symptom Diary (ASD) in a Phase 3, Placebo-Controlled Study of Once-Daily, Oral Paltusotine in Patients With Acromegaly Switched From Injected Octreotide or Lanreotide (ENDO 2024) - P3 | "Fifty-eight patients (paltusotine, n=30; placebo, n=28) were enrolled: mean (±SD) age 54.9±13.7 years; 55.2% female; prior treatment octreotide LAR (n=34) or lanreotide depot (n=24). Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO."

Clinical • P3 data • Acromegaly • Carcinoid Syndrome • Endocrine Cancer • Endocrine Disorders • Fatigue • Musculoskeletal Diseases • Musculoskeletal Pain • Oncology • Orthopedics • Pain • Pituitary Gland Carcinoma • IGF1 • SSTR

SI02-06. Paltusotine: A Novel, Investigational Oral Small Molecule Somatostatin Receptor Ligand for Acromegaly (ENDO 2024) - "For questions about how the sponsor will handle your information or to unsubscribe from their marketing communications, please contact the sponsor directly or refer to its privacy policy. For questions related to how the Endocrine Society shares information, please refer to the Society's Privacy Policy."

Acromegaly • Endocrine Disorders • Pain • Pituitary Gland Carcinoma • IGF1 • SSTR

Investigational drugs for the Treatment of Acromegaly: new agents to transform therapy. (PubMed, Expert Opin Investig Drugs) - "The aim of current review is to provide a detailed update about investigational drugs for acromegaly treatment currently under investigation as paltusotine, ONO-5788, AP102, GT-02037, ISIS 766,720, CAM2024, Lanreotide PRF, DP1038, MTD201, solid dose injection of octreotide. Current studies are addressing patient's needing for both new molecules and less invasive routes of administration for already existing drugs. It cannot be ruled out that drugs currently used for other disease such as cancers could be considered in the future for the treatment of acromegaly."

Journal • Review • Acromegaly • Endocrine Disorders • Oncology

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2) (clinicaltrials.gov) - P3 | N=111 | Active, not recruiting | Sponsor: Crinetics Pharmaceuticals Inc. | Trial completion date: Jan 2026 ➔ Jan 2028

Trial completion date • Acromegaly • Endocrine Disorders • IGF1

PATHFNDR 1: A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (clinicaltrials.gov) - P3 | N=58 | Active, not recruiting | Sponsor: Crinetics Pharmaceuticals Inc. | Trial completion date: Jun 2025 ➔ Jun 2027

Trial completion date • Acromegaly • Endocrine Disorders • IGF1 • SSTR

ORAL PALTUSOTINE MAINTAINS IGF-I, GH, AND SYMPTOM CONTROL IN PATIENTS WITH ACROMEGALY SWITCHED FROM INJECTED SOMATOSTATIN RECEPTOR LIGAND MONOTHERAPY: PHASE 3, PATHFNDR-1 STUDY RESULTS (ICE-EDEC 2024) - P3 | "In participants with biochemically controlled acromegaly who were switched to once-daily, oral paltusotine, IGF-1, GH, and symptom control were maintained, and AEs related to acromegaly were lower on paltusotine than on placebo."

Clinical • Monotherapy • P3 data • Acromegaly • Carcinoid Syndrome • Endocrine Cancer • Endocrine Disorders • Oncology • Pituitary Gland Carcinoma • IGF1 • SSTR

Crinetics Announces Positive Topline Results From Phase 2 Trial of Paltusotine For The Treatment of Carcinoid Syndrome (Crinetics) - '"I am excited about the clinical improvements that paltusotine demonstrated for patients with carcinoid syndrome in this study,' said Aman Chauhan, M.D...'There is a critical need for better treatment options for patients with neuroendocrine tumors who experience carcinoid syndrome. The results from this study of paltusotine are highly encouraging and I look forward to the next stage in its development.'"

Media quote • P2 data