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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Commercial
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 SV | tesamorelin | Theratechnologies | N-22505 RX | 2011-11-29 | 1 products |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| egrifta sv | Biologic Licensing Application | 2024-12-12 |
| egrifta wr | Biologic Licensing Application | 2025-03-31 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hiv-associated lipodystrophy syndrome | EFO_1001348 | D039682 | — |
Agency Specific
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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 |
|---|---|---|---|---|---|---|---|---|---|
| Lipodystrophy | D008060 | — | E88.1 | — | — | 2 | 1 | 4 | 7 |
| Hiv | D006678 | — | O98.7 | 1 | — | — | 1 | 3 | 5 |
| Hiv-associated lipodystrophy syndrome | D039682 | EFO_1001348 | — | — | — | — | 1 | 2 | 3 |
| Laron syndrome | D046150 | Orphanet_633 | E34.321 | — | 1 | — | 1 | — | 2 |
| Body composition | D001823 | — | — | — | — | — | 1 | — | 1 |
| Retinal diseases | D012164 | — | H35.9 | — | — | — | 1 | — | 1 |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | 2 | — | 2 | 5 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Abdominal obesity | D056128 | — | — | — | 3 | — | — | 1 | 4 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 2 | — | — | 1 | 3 |
| Cognitive dysfunction | D060825 | — | G31.84 | 1 | 2 | — | — | — | 3 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | 1 | — | — | 1 | 2 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 1 | — | — | 1 | 2 |
| Fatty liver | D005234 | EFO_0003934 | — | — | 1 | — | — | 1 | 2 |
| Aging | D000375 | GO_0007568 | R41.81 | — | 2 | — | — | — | 2 |
| Wounds and injuries | D014947 | — | T14.8 | — | 2 | — | — | — | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | — | — | — | 1 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 1 | — | — | — | 1 |
Show 12 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv seropositivity | D006679 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | — | — | — | 2 | 2 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 1 | 1 |
| Healthy volunteers/patients | — | — | — | — | — | — | — | 1 | 1 |
| Hiv-2 | D015498 | — | — | — | — | — | — | 1 | 1 |
| Immunologic deficiency syndromes | D007153 | — | D84.9 | — | — | — | — | 1 | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | — | — | 1 | 1 |
| Sleep apnea syndromes | D012891 | EFO_0003877 | G47.3 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tesamorelin |
| INN | tesamorelin |
| 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 class | prehormones or hormone-release stimulating peptides: growth hormone-release stimulating peptides |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1237026 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | MQG94M5EEO (ChemIDplus, GSRS) |
Target
Agency Approved
GHRHR
GHRHR
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Additional graphs summarizing 276 documents
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Safety
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3,555 adverse events reported
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