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| Routes of administration | Oral |
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| Eliminationhalf-life | 6–7 hours[1] |
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| Formula | C31H42N6O3 |
| Molar mass | 546.716 g·mol−1 |
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Anamorelin (INN) (developmental code namesONO-7643,RC-1291,ST-1291), also known asanamorelin hydrochloride (USAN,JAN), is anon-peptide,orally-active,centrally-penetrant, selectiveagonist of theghrelin/growth hormone secretagogue receptor (GHSR) withappetite-enhancing andanabolic effects which is under development byHelsinn Healthcare SA for the treatment ofcancer cachexia and anorexia.[2][3][4]
Anamorelin significantly increases plasma levels ofgrowth hormone (GH),insulin-like growth factor 1 (IGF-1), andinsulin-like growth factor-binding protein 3 (IGFBP-3) in humans, without affecting plasma levels ofprolactin,cortisol,insulin,glucose,adrenocorticotropic hormone (ACTH),luteinizing hormone (LH),follicle-stimulating hormone (FSH), orthyroid-stimulating hormone (TSH).[3][5] In addition, anamorelin significantly increasesappetite, overallbody weight,lean body mass, andmuscle strength,[4][5] with increases in body weight correlating directly with increases in plasma IGF-1 levels.[3]
As of February 2016, anamorelin has completedphase IIIclinical trials for the treatment of cancer cachexia and anorexia associated withnon-small-cell lung carcinoma.[6][7]
On 18 May 2017, theEuropean Medicines Agency recommended the refusal of the marketing authorisation for the medicinal product, intended for the treatment of anorexia, cachexia or unintended weight loss in patients with non-small cell lung cancer.Helsinn requested a re-examination of the initial opinion. After considering the grounds for this request, the European Medicines Agency re-examined the opinion, and confirmed the refusal of the marketing authorisation on 14 September 2017.[8]The European Medicines Agency concluded that the studies show a marginal effect of anamorelin on lean body mass and no proven effect on hand grip strength or patients’ quality of life. In addition, following an inspection at clinical study sites, the agency considered that the safety data on the medicine had not been recorded adequately. Therefore, the agency was of the opinion that the benefits of anamorelin did not outweigh its risks.[9]
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