Levomefolate calcium
/ /, Beyaz, Safyral, Tydemy (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
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| hemic and lymphatic diseases | D006425 |
| nutritional and metabolic diseases | D009750 |
Trade Name
FDA
EMA
Combinations
Beyaz, Drospirenone, ethinyl estradiol levomefolate, Safyral, Tydemy
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 |
|---|---|---|
| drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium | ANDA | 2023-12-19 |
| drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium | NDA authorized generic | 2023-05-19 |
| enbrace hr | unapproved drug other | 2025-01-02 |
| enlyte | unapproved drug other | 2022-07-01 |
| multi-vit-flor | unapproved drug other | 2024-04-30 |
| paxlyte | unapproved drug other | 2024-12-19 |
| poly-viflor | unapproved drug other | 2023-08-31 |
| prenate pixie | unapproved drug other | 2025-05-14 |
| safyral | New Drug Application | 2022-04-29 |
| select ob | unapproved drug other | 2014-09-22 |
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Indications
FDA
EMA
Agency Specific
FDA
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ATC Codes
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HCPCS
No data
Clinical
Clinical Trials
79 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | — | — | 2 | 4 | 6 |
| Depression | D003863 | — | F33.9 | — | — | — | 2 | 3 | 5 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | — | 2 | 2 | 4 |
| Peripheral nervous system diseases | D010523 | — | G64 | — | — | — | 1 | 3 | 4 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | — | — | — | 1 | 3 | 4 |
| Pregnancy rate | D018873 | — | — | — | — | — | 1 | 2 | 3 |
| Syndrome | D013577 | — | — | — | — | 1 | 1 | 1 | 3 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | 2 | 1 | 3 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | 1 | 1 | — | 2 |
| Nutrition disorders | D009748 | EFO_0001069 | — | — | — | — | 1 | — | 1 |
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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 | — | 3 | — | 2 | 9 |
| Colonic neoplasms | D003110 | — | C18 | — | 2 | 1 | — | — | 3 |
| Rectal neoplasms | D012004 | — | — | — | 2 | 1 | — | — | 3 |
| Colorectal neoplasms | D015179 | — | — | 1 | 1 | 1 | — | — | 2 |
| Habitual abortion | D000026 | EFO_1000954 | N96 | — | 1 | 2 | — | — | 2 |
| Neural tube defects | D009436 | — | Q00.0 | — | — | 1 | — | — | 1 |
| Spinal dysraphism | D016135 | EFO_1001210 | Q05 | — | — | 1 | — | — | 1 |
| Recurrence | D012008 | — | — | — | 1 | 1 | — | — | 1 |
| Hyperkinesis | D006948 | — | — | — | 1 | 1 | — | — | 1 |
| Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 2 | 2 | — | — | — | 3 |
| Adenocarcinoma | D000230 | — | — | 1 | 2 | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | 1 | 1 | — | — | — | 1 |
| Malaria | D008288 | EFO_0001068 | B54 | 1 | 1 | — | — | — | 1 |
| Pancreatic ductal carcinoma | D021441 | — | — | 1 | 1 | — | — | — | 1 |
| Brain injuries | D001930 | — | S06.9 | 1 | 1 | — | — | — | 1 |
| Consciousness disorders | D003244 | — | — | 1 | 1 | — | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | 1 | — | — | — | 1 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 1 | — | — | — | 1 |
| Fatty liver | D005234 | EFO_0003934 | — | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Wounds and injuries | D014947 | — | T14.8 | 1 | — | — | — | 1 | 2 |
| Glioma | D005910 | EFO_0000520 | — | 1 | — | — | — | — | 1 |
| Carcinoma | D002277 | — | C80.0 | 1 | — | — | — | — | 1 |
| Ovulation inhibition | D034445 | — | — | 1 | — | — | — | — | 1 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 1 | — | — | — | — | 1 |
| Chronic progressive multiple sclerosis | D020528 | EFO_0003840 | — | 1 | — | — | — | — | 1 |
| Sclerosis | D012598 | — | — | 1 | — | — | — | — | 1 |
| Leukemia | D007938 | — | C95 | 1 | — | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | — | — | — | — | 1 |
| Myeloid leukemia | D007951 | — | C92 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 4 | 4 |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | — | — | — | — | 3 | 3 |
| Pregnancy-induced hypertension | D046110 | — | O13 | — | — | — | — | 2 | 2 |
| Memory disorders | D008569 | — | — | — | — | — | — | 2 | 2 |
| Anemia | D000740 | EFO_0004272 | D64.9 | — | — | — | — | 2 | 2 |
| Eclampsia | D004461 | — | O15 | — | — | — | — | 2 | 2 |
| Hyperhomocysteinemia | D020138 | — | — | — | — | — | — | 2 | 2 |
| Healthy volunteers/patients | — | — | — | — | — | — | — | 2 | 2 |
| Impulsive behavior | D007175 | — | — | — | — | — | — | 1 | 1 |
| Blood pressure | D001794 | EFO_0004325 | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Levomefolate calcium |
| INN | levomefolic acid |
| Description | Levomefolic acid (INN, also known as L-5-MTHF, L-methylfolate and L-5-methyltetrahydrofolate and (6S)-5-methyltetrahydrofolate, and (6S)-5-MTHF) is the primary biologically active form of folate used at the cellular level for DNA reproduction, the cysteine cycle and the regulation of homocysteine. It is also the form found in circulation and transported across membranes into tissues and across the blood–brain barrier. In the cell, L-methylfolate is used in the methylation of homocysteine to form methionine and tetrahydrofolate (THF). THF is the immediate acceptor of one carbon unit for the synthesis of thymidine-DNA, purines (RNA and DNA) and methionine. The un-methylated form, folic acid (vitamin B9), is a synthetic form of folate, and must undergo enzymatic reduction by dihydrofolate reductase (DHFR) to become biologically active.
|
| 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 | 151533-22-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1615371 |
| ChEBI ID | — |
| PubChem CID | 444412 |
| DrugBank | DBSALT001276 |
| UNII ID | 8S95DH25XC (ChemIDplus, GSRS) |
Target
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Variants
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Financial
Revenue by drug
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€
£
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Estimated US medical usage
Levomefolate calcium
+
Ethinyl estradiol
+
Drospirenone
+
Levomefolic acid
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
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Safety
Black-box Warning
Black-box warning for: Drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium, Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium, Enlyte, Prenate pixie, Safyral, Select ob, Select-ob plus dha, Vitafol, Vitafol fe plus
Adverse Events
Top Adverse Reactions
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557 adverse events reported
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