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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
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 |
|---|---|---|
| beyaz | New Drug Application | 2026-03-02 |
| drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium | ANDA | 2025-12-08 |
| drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium | New Drug Application | 2026-03-04 |
| enbrace hr | unapproved drug other | 2026-02-10 |
| enlyte | unapproved drug other | 2022-07-01 |
| multi-vit-flor | unapproved drug other | 2024-04-30 |
| paxlyte | unapproved drug other | 2025-12-08 |
| poly-viflor | unapproved drug other | 2023-08-31 |
| prenate pixie | unapproved drug other | 2025-05-14 |
| safyral | New Drug Application | 2026-03-04 |
Show 5 more
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
80 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Depression | D003863 | — | F33.9 | — | — | — | 2 | 5 | 7 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | — | 2 | 2 | 4 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | — | — | — | 1 | 3 | 4 |
| Pregnancy rate | D018873 | — | — | — | — | — | 1 | 2 | 3 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | — | 1 | 2 | 3 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | — | — | 2 | 1 | 3 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | 1 | 1 | — | 2 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | — | — | 1 | 1 | 2 |
| Fetal nutrition disorders | D048070 | — | — | — | — | — | 1 | — | 1 |
| Neurodevelopmental disorders | D065886 | — | F89 | — | — | — | 1 | — | 1 |
Show 5 more
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 | — | — | 2 | — | — | 2 |
| Neoplasms | D009369 | — | C80 | — | — | 1 | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | — | 1 | — | — | 1 |
| Syndrome | D013577 | — | — | — | — | 1 | — | — | 1 |
| Hyperkinesis | D006948 | — | — | — | 1 | 1 | — | — | 1 |
Show 1 more
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 |
| Gastrointestinal neoplasms | D005770 | — | C26.9 | 1 | 1 | — | — | — | 1 |
| Gastrointestinal diseases | D005767 | — | — | 1 | 1 | — | — | — | 1 |
| Intestinal neoplasms | D007414 | — | C26.0 | 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 |
Show 3 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioma | D005910 | EFO_0000520 | — | 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 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | — | — | — | — | 1 |
| Papilledema | D010211 | EFO_1001074 | H35.81 | 1 | — | — | — | — | 1 |
| Acute kidney injury | D058186 | — | N17 | 1 | — | — | — | — | 1 |
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 |
| Iron deficiencies | D000090463 | — | E61.1 | — | — | — | — | 3 | 3 |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | — | — | — | — | 3 | 3 |
| Memory disorders | D008569 | — | — | — | — | — | — | 2 | 2 |
| Anemia | D000740 | EFO_0004272 | D64.9 | — | — | — | — | 2 | 2 |
| Hyperhomocysteinemia | D020138 | — | — | — | — | — | — | 2 | 2 |
| Healthy volunteers/patients | — | — | — | — | — | — | — | 2 | 2 |
| Impulsive behavior | D007175 | — | — | — | — | — | — | 1 | 1 |
| Blood pressure | D001794 | EFO_0004325 | — | — | — | — | — | 1 | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
Show 31 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Levomefolate calcium
+
Ethinyl estradiol
+
Drospirenone
+
Levomefolic acid
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
No data
Safety
Black-box Warning
Black-box warning for: Beyaz, 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, Tydemy, Vitafol, Vitafol fe plus
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
571 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use