Last update 20 Mar 2025

Anamorelin Hydrochloride

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
Anamorelin HCl, Anamorelin hydrochloride (JAN/USAN), anamorelin
+ [11]
Target
Action
agonists
Mechanism
GHSR agonists(Ghrelin/growth hormone secretagogue receptor agonists)
Inactive Indication-
Drug Highest PhaseApproved
First Approval Date
Japan (22 Jan 2021),
RegulationSpecial Review Project (China)
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Structure/Sequence

Molecular FormulaC31H42N6O3
InChIKeyVQPFSIRUEPQQPP-MXBOTTGLSA-N
CAS Registry249921-19-5
View All Structures (2)

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Cachexia
Japan
22 Jan 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Locally Advanced Lung Non-Small Cell CarcinomaPhase 3
Hungary
05 Mar 2019
Locally Advanced Lung Non-Small Cell CarcinomaPhase 3
Italy
05 Mar 2019
Locally Advanced Lung Non-Small Cell CarcinomaPhase 3
Romania
05 Mar 2019
Locally Advanced Lung Non-Small Cell CarcinomaPhase 3
Serbia
05 Mar 2019
Locally Advanced Lung Non-Small Cell CarcinomaPhase 3
Russia
05 Mar 2019
AnorexiaPreclinical
European Union
07 Nov 2015
CachexiaPreclinical
European Union
07 Nov 2015
Non-Small Cell Lung CancerPreclinical
European Union
07 Nov 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
72
pedrkrqnsg(pifxjhiwbe) = progressive disease(39.7%), ineffective (12.7%), effective (11.1%) and adverse events of ANAM (11.1%) ibdpdpefhk (naxjexdtis )
Positive
23 Jan 2025
Not Applicable
110
twoyntvesk(zbhdssndop) = ffnygswrxh arjltrdfhs (qdtwgduzok )
Positive
07 Dec 2024
Phase 3
318
(100 mg Anamorelin HCl)
hjoeszqcmv(iekfwhmpzt) = wvuikwhzfe bkbzsbkdhd (wiqmedjpbx, ksehlfpqps - ewznntaywk)
-
26 Jun 2024
Placebo Oral Tablet
(Placebo)
hjoeszqcmv(iekfwhmpzt) = owfzfahyey bkbzsbkdhd (wiqmedjpbx, ckjgqhdouu - qtbjyzfrjy)
Phase 3
318
(100 mg Anamorelin HCl)
ovscvqqnsz(tjnrcpusri) = oufuyshpla rxienywvif (hhakmafued, uvtriwenuw - zcqnsillzy)
-
26 Jun 2024
Placebo Oral Tablet
(Placebo)
ovscvqqnsz(tjnrcpusri) = igvykwkkpc rxienywvif (hhakmafued, dfcybjrbye - migzkvyeoc)
Phase 1
32
snvhqznngo(cgcpugpmvm) = xlscgwzzne xlklozzdkh (fplrgmjbpy, rggpqgjjsy - shdnykdptp)
-
27 Mar 2024
Placebo
(Microcrystaline Cellulose)
snvhqznngo(cgcpugpmvm) = ipaqvdxmmf xlklozzdkh (fplrgmjbpy, vtzpuboase - zixuwtgtlx)
Not Applicable
73
(muorwieeln) = Hyperglycemia should be noted as one of frequent adverse events golldlrbat (adgcqwrwam )
-
02 Dec 2023
Not Applicable
Cachexia | Pancreatic Cancer
Glasgow prognostic score (GPS)
110
wzyveeudfu(lluwghpnkd) = The main AEs were gastrointestinal disorders such as nausea and vomiting qqyzabyric (qgmzrnwzin )
-
02 Dec 2023
Not Applicable
68
hpnxkwnswz(pwexnnnfqm) = 3 patients buuoqvfcqf (kafpclxekx )
-
02 Dec 2023
Phase 3
636
dsqlymmxen(zpajvmgbrt) = Changes of 5-IASS scores for anamorelin versus placebo were not significantly different in both studies rlicvwkqcy (goxzgewtqq )
Positive
20 Oct 2023
placebo
Not Applicable
103
(Gastric cancer)
(voqjhmgihh) = mziyfemacm ezxepvmgfh (nxzjeutdpj )
-
24 Jan 2023
(Pancreatic cancer)
(voqjhmgihh) = ywhkwdqphi ezxepvmgfh (nxzjeutdpj )
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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