Overview
No overview information available.
Indication
Investigated for use/treatment in cachexia and anorexia.
Associated Conditions
No associated conditions information available.
Research Report
Comprehensive Analysis of Anamorelin (DB06645): A Ghrelin Receptor Agonist for Cancer Anorexia-Cachexia Syndrome
Executive Summary
Anamorelin is a first-in-class, orally bioavailable, small-molecule, selective ghrelin receptor agonist developed to address the profound unmet medical need of cancer anorexia-cachexia syndrome (CACS).[1] CACS is a debilitating multifactorial condition characterized by loss of appetite and a progressive wasting of skeletal muscle and adipose tissue, which is associated with poor prognosis, reduced tolerance to cancer therapies, and diminished quality of life.[4] The therapeutic rationale for Anamorelin is rooted in its ability to mimic the physiological actions of ghrelin, an endogenous peptide often termed the "hunger hormone".[7]
The core mechanism of Anamorelin involves potent and specific stimulation of the growth hormone secretagogue receptor type 1a (GHSR-1a).[7] This action initiates a dual-pronged physiological response. Centrally, it stimulates hypothalamic pathways to increase appetite and food intake (orexigenic effect). Concurrently, it triggers the pulsatile release of growth hormone (GH) from the pituitary gland, which in turn stimulates hepatic production of insulin-like growth factor-1 (IGF-1). This activation of the GH/IGF-1 axis promotes anabolism, leading to the synthesis of muscle protein and an increase in lean body mass (LBM).[7]
Pivotal clinical evidence for Anamorelin is derived from the global, Phase III ROMANA 1 and ROMANA 2 trials. These studies unequivocally demonstrated that Anamorelin treatment in patients with non-small cell lung cancer (NSCLC) and cachexia resulted in a statistically significant increase in LBM compared to placebo over 12 weeks. However, the program failed to meet its co-primary functional endpoint, showing no significant improvement in handgrip strength (HGS).[12]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2021/04/14 | Phase 2 | Recruiting | |||
2019/07/16 | Phase 1 | Completed | |||
2018/11/15 | Phase 3 | Completed | |||
2018/11/15 | Phase 3 | Completed | |||
2018/08/20 | Early Phase 1 | Active, not recruiting | |||
2017/01/30 | Phase 2 | Active, not recruiting | |||
2012/01/09 | Phase 2 | Terminated | |||
2011/07/18 | Phase 3 | Completed | |||
2011/07/04 | Phase 3 | Completed | |||
2011/07/04 | Phase 3 | Completed |
FDA Drug Approvals
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No FDA approvals found for this drug. |
EMA Drug Approvals
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No EMA approvals found for this drug. |
HSA Drug Approvals
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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No UK EMC drug information found for this drug. |
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