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
No data
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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Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| infertility | EFO_0000545 | 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 | — | E88.1 | — | — | 2 | — | 2 | 4 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | 2 | — | 1 | 4 |
| Infertility | D007246 | EFO_0000545 | — | — | — | 1 | — | — | 1 |
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 |
| Aging | D000375 | GO_0007568 | R41.81 | — | 3 | — | — | — | 3 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 1 | — | — | 1 | 2 |
| Fatty liver | D005234 | EFO_0003934 | — | — | 1 | — | — | 1 | 2 |
| Cognitive dysfunction | D060825 | — | G31.84 | 1 | 1 | — | — | — | 2 |
| Heart failure | D006333 | EFO_0003144 | 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 | — | O98.7 | 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 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | — | — | — | 1 | 1 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | — | — | — | 1 | 1 |
| Hiv-2 | D015498 | — | — | — | — | — | — | 1 | 1 |
| Immunologic deficiency syndromes | D007153 | — | 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
No data
Variants
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Financial
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Trends
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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20 adverse events reported
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