Clinical Trials

Multiple clinical trials sponsored by Crinetics Pharmaceuticals Inc. evaluate the therapeutic profile of paltusotine across Phase 1, Phase 2, and Phase 3 studies. Encompassing healthy volunteers as well as patients with acromegaly and carcinoid syndrome—including carcinoid tumors of the gastrointestinal tract and liver—these completed, recruiting, and terminated investigations assess the safety, pharmacokinetics, and therapeutic efficacy of paltusotine in suppressing pathological hormone secretion.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07087054 RECRUITING
Carcinoid Syndrome; Carcinoid; Carcinoid Tumor; Carcinoid Tumor of Ileum; Carcinoid Tumor of Cecum; Carcinoid Tumor of Liver; Carcinoid Tumor of Pancreas; Carcinoid Syndrome Diarrhea; Carcinoid Intestine Tumor
Crinetics Pharmaceuticals Inc.
 2025-11-19 PHASE3
NCT04261712 TERMINATED
Acromegaly
Crinetics Pharmaceuticals Inc.
 2020-01-29 PHASE2
NCT05361668 COMPLETED
Carcinoid Syndrome; Carcinoid; Carcinoid Tumor; Carcinoid Tumor of Ileum; Carcinoid Tumor of Cecum; Carcinoid Syndrome Diarrhea; Carcinoid Intestine Tumor; Carcinoid Tumor of Liver; Carcinoid Tumor of Pancreas
Crinetics Pharmaceuticals Inc.
 2022-04-22 PHASE2
NCT05192382 TERMINATED
Acromegaly
Crinetics Pharmaceuticals Inc.
 2021-12-17 PHASE3
NCT04837040 TERMINATED
Acromegaly
Crinetics Pharmaceuticals Inc.
 2021-05-12 PHASE3
NCT03789656 COMPLETED
Acromegaly
Crinetics Pharmaceuticals Inc.
 2019-03-12 PHASE2
NCT03792555 COMPLETED
Acromegaly
Crinetics Pharmaceuticals Inc.
 2019-03-11 PHASE2
NCT04246749 Completed
Healthy Volunteers
Crinetics Pharmaceuticals Inc.
 2019-09-17 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-08-04)

Check the Paltusotine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Paltusotine functions as a selective nonpeptide agonist of the somatostatin type 2 (SST2) receptor, binding the receptor to activate inhibitory G-protein signaling pathways that suppress intracellular adenylate cyclase activity and reduce cyclic adenosine monophosphate (cAMP) levels. This signaling inhibition decreases calcium influx and downstream hormone exocytosis in neuroendocrine cells, thereby providing clinical relevance by suppressing excess growth hormone (GH) and insulin-like growth factor 1 (IGF-1) secretion in acromegaly, as well as controlling carcinoid syndrome symptoms.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.