Sermorelin acetate
Geref (sermorelin acetate) is a protein pharmaceutical. Sermorelin acetate was first approved as Geref on 1990-12-28. It is used to treat emaciation and infertility in the USA. The pharmaceutical is active against growth hormone-releasing hormone receptor.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| urogenital diseases | D000091642 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sermorelin acetate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| GEREF | EMD Serono | N-019863 DISCN | 1990-12-28 | 1 products, RLD |
| GEREF | EMD Serono | N-020443 DISCN | 1997-09-26 | 2 products, RLD |
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FDA
EMA
No data
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| infertility | HP_0000789 | D007246 | — |
| emaciation | — | D004614 | — |
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
— H01AC04: Sermorelin
V: Various drug classes in atc
— V04: Diagnostic agents
— V04C: Other diagnostic agents in atc
— V04CD: Pituitary function test diagnostic agents
— V04CD03: Sermorelin
HCPCS
Code | Description |
|---|---|
| Level 2: Q0515-Q0515 | Sermorelin Acetate |
| Q0515 | Injection, sermorelin acetate, 1 microgram |
Clinical
Clinical Trials
27 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Laron syndrome | D046150 | Orphanet_633 | E34.321 | 1 | 1 | 1 | 1 | 3 | 7 |
| Pituitary dwarfism | D004393 | EFO_1001109 | E23.0 | 1 | — | 1 | 1 | 2 | 5 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | 1 | — | 1 | — | 2 | 4 |
| Lipodystrophy | D008060 | HP_0009125 | E88.1 | — | — | 2 | — | 2 | 4 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | 2 | — | 1 | 4 |
| Infertility | D007246 | HP_0000789 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Abdominal obesity | D056128 | HP_0001956 | — | — | 3 | — | — | 1 | 4 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 2 | — | — | 1 | 3 |
| Aging | D000375 | GO_0007568 | R41.81 | — | 3 | — | — | — | 3 |
| Liver diseases | D008107 | HP_0002910 | 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 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | 1 | 1 | — | — | — | 2 |
| Heart failure | D006333 | HP_0001635 | I50 | — | 1 | — | — | — | 1 |
| Frailty | D000073496 | — | R53.1 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | 1 | 2 |
| Hiv | D006678 | — | — | 1 | — | — | — | 1 | 2 |
| Hiv seropositivity | D006679 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv-associated lipodystrophy syndrome | D039682 | EFO_1001348 | — | — | — | — | — | 2 | 2 |
| Acromegaly | D000172 | — | — | — | — | — | — | 1 | 1 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 1 | 1 |
| Sleep wake disorders | D012893 | — | G47 | — | — | — | — | 1 | 1 |
| Parasomnias | D020447 | — | G47.5 | — | — | — | — | 1 | 1 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | — | — | — | 1 | 1 |
| Hiv-2 | D015498 | — | — | — | — | — | — | 1 | 1 |
| Immunologic deficiency syndromes | D007153 | HP_0002721 | D84.9 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Sermorelin acetate |
| INN | sermorelin |
| Description | Somatoliberin [Precursor] |
| Classification | Protein |
| 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 | 86168-78-7 |
| RxCUI | 56188 |
| ChEMBL ID | CHEMBL1201490 |
| ChEBI ID | — |
| PubChem CID | 16132413 |
| DrugBank | DB00010 |
| UNII ID | 89243S03TE (ChemIDplus, GSRS) |
Target
Agency Approved
GHRHR
GHRHR
Alternate
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Trends
PubMed Central
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Additional graphs summarizing 136 documents
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Safety
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Adverse Events
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17 adverse events reported
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