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Drug ReportsTesamorelin
Tesamorelin
Egrifta SV (tesamorelin) is a protein pharmaceutical. Tesamorelin was first approved as Egrifta on 2010-11-10. It is used to treat hiv-associated lipodystrophy syndrome in the USA. The pharmaceutical is active against growth hormone-releasing hormone receptor.
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Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
nutritional and metabolic diseasesD009750
immune system diseasesD007154
Trade Name
FDA
EMA
Egrifta sv (discontinued: Egrifta sv)
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Tesamorelin
Tradename
Proper name
Company
Number
Date
Products
Egrifta SVtesamorelinTheratechnologiesN-22505 RX2011-11-29
1 products
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
egrifta svBiologic Licensing Application2024-12-12
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
H: Systemic hormonal preparations, excl. sex hormones and insulins
H01: Pituitary and hypothalamic hormones and analogues
H01A: Anterior pituitary lobe hormones and analogues
H01AC: Somatropin and somatropin agonists
H01AC06: Tesamorelin
HCPCS
No data
Clinical
Clinical Trials
23 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HivD006678O98.71113
Retinal diseasesD012164H35.911
Diabetic retinopathyD003930EFO_000377011
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B2022
LipodystrophyD008060E88.122
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Type 2 diabetes mellitusD003924EFO_0001360E1111
Diabetes mellitusD003920EFO_0000400E08-E1311
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.911
Lung diseasesD008171EFO_0003818J98.411
Wasting syndromeD01928211
Obstructive lung diseasesD00817311
CachexiaD002100R6411
Muscular atrophyD00913311
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv seropositivityD00667911
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTesamorelin
INNtesamorelin
Description
Tesamorelin (INN) (trade name Egrifta) is a synthetic form of growth-hormone-releasing hormone (GHRH) which is used in the treatment of HIV-associated lipodystrophy, approved initially in 2010. It is produced and developed by Theratechnologies, Inc. of Canada. The drug is a synthetic peptide consisting of all 44 amino acids of human GHRH with the addition of a trans-3-hexenoic acid group.
Classification
Peptide
Drug classprehormones or hormone-release stimulating peptides: growth hormone-release stimulating peptides
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID
RxCUI
ChEMBL IDCHEMBL1237026
ChEBI ID
PubChem CID
DrugBank
UNII IDMQG94M5EEO (ChemIDplus, GSRS)
Target
Agency Approved
GHRHR
GHRHR
Organism
Homo sapiens
Gene name
GHRHR
Gene synonyms
NCBI Gene ID
Protein name
growth hormone-releasing hormone receptor
Protein synonyms
GHRH receptor, GRF receptor, GRFR, Growth hormone-releasing factor receptor
Uniprot ID
Mouse ortholog
Ghrhr (14602)
growth hormone-releasing hormone receptor (Q0VB62)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,321 adverse events reported
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