Levomefolate calcium
Beyaz, Safyral (levomefolate calcium) is a small molecule pharmaceutical. Levomefolate calcium was first approved as Beyaz on 2010-09-24. It is used to treat folic acid deficiency and megaloblastic anemia in the USA.
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Commercial
Trade Name
FDA
EMA
Combinations
Beyaz, Safyral (generic drugs available since 2016-10-11)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| beyaz | New Drug Application | 2022-04-29 |
| drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium | New Drug Application | 2022-04-29 |
| tydemy | ANDA | 2022-06-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| folic acid deficiency | EFO_0001070 | D005494 | E53.8 |
| megaloblastic anemia | — | D000749 | D53.1 |
Agency Specific
FDA
EMA
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
12 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Contraception | D003267 | 4 | — | 1 | — | — | 5 | ||
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ovulation inhibition | D034445 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vitamin b 12 deficiency | D014806 | EFO_0000734 | E53.8 | — | — | — | — | 1 | 1 |
| Nervous system diseases | D009422 | G00-G99 | — | — | — | — | 1 | 1 | |
| Angelman syndrome | D017204 | Orphanet_72 | Q93.51 | — | — | — | — | 1 | 1 |
| Healthy volunteers/patients | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | LEVOMEFOLATE CALCIUM |
| INN | levomefolic acid |
| Description | 5-methyltetrahydrofolic acid is a tetrahydrofolic acid that is 5,6,7,8-tetrahydrofolic acid substituted by a methyl group at position 5. It has a role as a human metabolite. It is functionally related to a 5,6,7,8-tetrahydrofolic acid. It is a conjugate acid of a 5-methyltetrahydrofolate(2-). |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CN1c2c([nH]c(N)nc2=O)NC[C@@H]1CNc1ccc(C(=O)N[C@@H](CCC(=O)[O-])C(=O)[O-])cc1.[Ca+2] |
Identifiers
| PDB | — |
| CAS-ID | 31690-09-2 |
| RxCUI | 1025342 |
| ChEMBL ID | CHEMBL1615371 |
| ChEBI ID | — |
| PubChem CID | 135398561 |
| DrugBank | DBSALT001276 |
| UNII ID | 8S95DH25XC (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
No data
Variants
Clinical Variant
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Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 361 documents
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Safety
Black-box Warning
Black-box warning for: Beyaz, Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium, Tydemy
Adverse Events
Top Adverse Reactions
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1,831 adverse events reported
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