Drugs / Anamorelin
Anamorelin
also known as
Anamorelin HCl · Anamorelin Hydrochloride · RC-1291 · Anamorelin hydrochloride (HCl) · Anamorelina · Anamoreline · Ono-7643 · RC-1291 HCl · +1 more
Small molecule targets GHSR via activation
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Refused (EMA) | EU (EMA) | Adlumiz | — | 2017-11-16 | europa.eu ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 26 trials · 1 met primary | ||||||
| Phase 2 | NCT04844970 | Apr → Nov 2023 | pancreatic ductal adenocarcinoma | Lahey Clinic | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03035409 | Feb 2017 → Dec 2019 overdue | metastatic malignant neoplasm | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01505764 | Jun 2012 → Jan 2016 | — | VA Office of Research and Development | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00622193 | Mar 2008 → Dec 2009 | non-small cell lung carcinoma | Helsinn Therapeutics (U.S.), Inc | Completed | No outcome recorded |
| Phase 2 | NCT00378131 | Sep 2006 → Apr 2007 | — | Helsinn Therapeutics (U.S.), Inc | Completed | No outcome recorded |
| Phase 2 | NCT00219817 | Jun 2005 → Oct 2006 | — | Helsinn Therapeutics (U.S.), Inc | Completed | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03637816 | Nov 2018 → Dec 2026 expected | eating disorder, non-small cell lung carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT03743064 | May 2019 → Dec 2022 | hypoproteinemia, hypercatabolic, non-small cell lung carcinoma | Helsinn Healthcare SA | Completed | Mixed |
| Phase 3 | NCT03743051 | Mar 2019 → Feb 2023 | hypoproteinemia, hypercatabolic, non-small cell lung carcinoma | Helsinn Healthcare SA | Completed | Mixed |
| Phase 3 | NCT01395914 | Jul 2011 → Jun 2014 | hypoproteinemia, hypercatabolic, non-small cell lung carcinoma | Helsinn Therapeutics (U.S.), Inc | Completed | No outcome recorded |
| Phase 3 | NCT01387269 | Jul 2011 → Jan 2014 | hypoproteinemia, hypercatabolic, non-small cell lung carcinoma | Helsinn Therapeutics (U.S.), Inc | Completed | Mixed |
| Comparator or background therapy3 trials | ||||||
| Phase 1 | NCT04021706 Comparator | Dec 2019 → Jan 2023 | muscular atrophy, osteoporosis | Tufts University | Completed | No outcome recorded |
| Phase 2 | NCT00267358 Comparator | Nov 2005 → Oct 2006 | — | Helsinn Therapeutics (U.S.), Inc | Completed | No outcome recorded |
| Phase 3 | NCT01387282 Comparator | Jul 2011 → Nov 2013 | hypoproteinemia, hypercatabolic, non-small cell lung carcinoma | Helsinn Therapeutics (U.S.), Inc | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2021-01-22 | Ono Pharmaceutical Co., Ltd. | ONO Receives a Manufacturing and Marketing Approval of Adlumiz® (Anamorelin), a Ghrelin Receptor Agonist for the Treatment of Cancer Cachexia in Japan ono-pharma.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Anamorelin | “Anamorelin is an oral ghrelin-receptor agonist with appetite-enhancing and anabolic activity.” PMID 25524795 ↗ Dec 2014 |
| Known as | Anamorelin HCl | “Investigational: Anamorelin HCl; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.” NCT01387282 ↗4“Anamorelin HCl is an orally-active selective ghrelin receptor agonist which has shown anabolic and appetite-stimulating effects.” NCT04844970 ↗ “Anamorelin HCl, by virtue of its ghrelin agonist activity, may serve a role in the treatment of cancer cachexia.” NCT00622193 ↗ “100 mg anamorelin HCl (administered as 100 mg tablets in the fasted condition)” NCT03743064 ↗ “Arm 1 (Anamorelin HCl)” NCT01505764 ↗ |
| Known as | Anamorelin Hydrochloride | “nine weeks of treatment of oral anamorelin hydrochloride (anamorelin) (100 mg) and placebo” NCT03637816 ↗ |
| Known as | Anamorelin hydrochloride (HCl) | “This study is going to study the benefits of the use of the study drug, Anamorelin hydrochloride (HCl) in treatment or prevention of cachexia associated with cancer.” NCT01505764 ↗ |
| Known as | Anamorelina | ChEMBL registry synonym — accepted as the source's own label CHEMBL2110579 ↗ |
| Known as | Anamoreline | ChEMBL registry synonym — accepted as the source's own label CHEMBL2110579 ↗ |
| Known as | Ono-7643 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2110579 ↗ |
| Known as | RC-1291 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00378131 ↗ |
| Known as | RC-1291 HCl | ChEMBL registry synonym — accepted as the source's own label CHEMBL2110579 ↗ |
| Known as | ST-1291 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2110579 ↗ |
| Action | Activate | “Anamorelin is an oral ghrelin-receptor agonist” PMID 25524795 ↗ Dec 20141“Ghrelin receptor agonist” CHEMBL2110579 ↗ |
| Modality | Small molecule | — CHEMBL2110579 ↗ |
| Route | Oral | “Anamorelin is an oral ghrelin-receptor agonist with appetite-enhancing and anabolic activity.” PMID 25524795 ↗ Dec 2014 |
| Target | GHSR | “Ghrelin receptor agonist” CHEMBL2110579 ↗ |