AnaMorelin hydrochloride Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Multiple clinical trials across Phase I, Phase II, and Phase III evaluate anamorelin hydrochloride for treating cancer cachexia, anorexia, non-small cell lung cancer, and metastatic pancreatic cancer, primarily aiming to prevent weight loss and improve nutritional status. Sponsored by pharmaceutical companies and academic research institutions, these studies encompass completed, active but not recruiting, and terminated protocols.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03637816	ACTIVE_NOT_RECRUITING	Anorexia; Lung Non-Small Cell Carcinoma; Stage III Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8	M.D. Anderson Cancer Center	2018-11-27	PHASE2; PHASE3
NCT04844970	TERMINATED	Metastatic Pancreatic Cancer	Lahey Clinic	2023-04-01	PHASE2
NCT03743051	COMPLETED	Cachexia; Cancer; Non Small Cell Lung Cancer	Helsinn Healthcare SA	2019-03-05	PHASE3
NCT04021706	COMPLETED	Sarcopenia; Osteopenia	Tufts University	2019-12-05	PHASE1
NCT03743064	COMPLETED	Cachexia; Cancer; Non Small Cell Lung Cancer	Helsinn Healthcare SA	2019-05-06	PHASE3
NCT03035409	ACTIVE_NOT_RECRUITING	Advanced Malignant Solid Neoplasm; C-Reactive Protein Measurement; Cancer Fatigue; Metastatic Malignant Solid Neoplasm; Recurrent Malignant Solid Neoplasm; Weight Loss	M.D. Anderson Cancer Center	2017-02-08	PHASE2
NCT01505764	TERMINATED	Cancer Cachexia	VA Office of Research and Development	2012-06	PHASE2
NCT01395914	COMPLETED	Cachexia; Non-Small Cell Lung Cancer	Helsinn Therapeutics (U.S.), Inc	2011-07	PHASE3
NCT01387269	COMPLETED	Cachexia; Non-Small Cell Lung Cancer	Helsinn Therapeutics (U.S.), Inc	2011-07	PHASE3
NCT01387282	COMPLETED	Cachexia; Non-Small Cell Lung Cancer	Helsinn Therapeutics (U.S.), Inc	2011-07	PHASE3
NCT00622193	COMPLETED	Carcinoma, Non-Small-Cell Lung	Helsinn Therapeutics (U.S.), Inc	2008-03	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-04-15)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Anamorelin hydrochloride functions as a potent, selective agonist of the ghrelin receptor with an EC50 of 0.74 nM, activating downstream signaling pathways that trigger growth hormone secretion and stimulate appetite-regulating centers in the central nervous system. This molecular activation promotes food intake and anabolic responses, demonstrating direct clinical relevance in counteracting progressive weight loss and muscle degradation in patients affected by cancer anorexia-cachexia syndrome and non-small cell lung cancer.

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>).