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Not Approved (US) Growth Hormone Axis

Anamorelin

also known as: Adlumiz, ONO-7643, RC-1291, anamorelin hydrochloride

Ono Pharmaceutical's oral ghrelin receptor agonist (Adlumiz) — approved in Japan in 2021 for cancer cachexia in non-small-cell lung, gastric, pancreatic, and colorectal cancers; FDA issued a Complete Response Letter in 2020 and anamorelin remains unapproved in the US.

A small-molecule orally active ghrelin receptor (GHS-R1a) agonist developed for cancer-associated cachexia. Approved in Japan in January 2021 as Adlumiz (Ono Pharmaceutical, licensed from Helsinn) for cachexia in non-small-cell lung, gastric, pancreatic, and colorectal cancers — the first pharmacologic agent approved anywhere for cancer cachexia as a specific indication. FDA issued a Complete Response Letter in 2020 citing insufficient evidence of muscle function benefit despite improvements in lean body mass and appetite; CHMP in Europe also issued a negative opinion. Remains investigational in the US.

Mechanism of action

Full agonist at the growth hormone secretagogue receptor type 1a (GHS-R1a, the ghrelin receptor) expressed in the hypothalamus and pituitary somatotrophs. Stimulates GH release and, independently, triggers downstream appetite and food intake signaling through NPY/AgRP hypothalamic circuits. Net clinical effect in cachexia is improved appetite, increased lean body mass, and modest weight gain, without meaningful improvements in physical function in the Phase 3 program.

Primary uses

  • Cancer cachexia — NSCLC, gastric, pancreatic, colorectal (Japan-approved)

Typical dosing

100 mg/day once daily (oral) (oral)

Administered on an empty stomach, per the Japanese label.

Regulatory status

Approved in Japan January 2021 as Adlumiz (Ono Pharmaceutical) for cachexia in non-small-cell lung, gastric, pancreatic, and colorectal cancer. FDA Complete Response Letter 2020 (Helsinn, formerly partnered with Ono) — approval denied on grounds that ROMANA Phase 3 program demonstrated lean body mass and appetite improvement but did not meet the co-primary endpoint of hand-grip strength. CHMP negative opinion 2017. Remains available only in Japan.

References

  1. [pubmed] Temel JS, et al. "Anamorelin in patients with non-small-cell lung cancer and cachexia (ROMANA 1 and ROMANA 2): results from two randomised, double-blind, phase 3 trials." Lancet Oncol, 2016;17:519-531.
  2. [manufacturer] Ono Pharmaceutical. Adlumiz prescribing information (Japan), 2021.
  3. [manufacturer] Helsinn Group. Press release regarding FDA Complete Response Letter for anamorelin, 2020.

Related peptides

MK-677

An orally active non-peptide ghrelin receptor agonist — included here by convention because it is universally marketed alongside peptide GH secretagogues. FDA warns of heart failure risk.

GHRP-2

A second-generation GHRP approved as a diagnostic agent in Japan, with more pronounced GH-releasing potency than GHRP-6 but a meaningful prolactin and cortisol rise at higher doses.

GHRP-6

The prototype GHRP — a hexapeptide ghrelin receptor agonist notable for pronounced hunger stimulation and less favorable cortisol/prolactin profile than newer GHRPs.

Macimorelin

An orally active ghrelin receptor agonist FDA-approved in 2017 as a diagnostic test for adult growth hormone deficiency — the only oral alternative to the insulin tolerance test.

Relamorelin

Motus Therapeutics' (formerly Rhythm, then Allergan) ghrelin agonist pentapeptide — Phase 2b results in diabetic gastroparesis were positive, Phase 3 development paused following Allergan's divestiture; status ambiguous as of 2026.

Guides & tools

Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.