Multiple clinical trials across Phase 1, Phase 2, and Phase 3 have evaluated anamorelin for treating cancer-related anorexia, cachexia, and weight loss in patients with non-small cell lung cancer and metastatic pancreatic cancer. Sponsored by corporate entities such as Helsinn Therapeutics and academic institutions including M.D. Anderson Cancer Center and Tufts University, these studies assess patient-reported outcomes, body weight changes, and overall tolerability. The trials feature varied recruitment statuses, including completed, active non-recruiting, and early terminated investigations.
| 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)
Mechanism and Biochemical Profile
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>).