Yasmin, Drovelis(drospirenone)
Angeliq, Beyaz, Drospirenone / Ethinyl Estradiol, Drospirenone / Ethinyl Estradiol /, Drovelis, Lo-zumandimine, Loryna, Lydisilka, Melamisa, Nextstellis, Nikki, Safyral, Slynd, Syeda, Tydemy, Yaela, Yasmin, Yaz, Zumandimine (drospirenone) is a small molecule pharmaceutical. Drospirenone was first approved as Yasmin on 2001-05-11. The pharmaceutical is active against mineralocorticoid receptor.
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Trade Name
FDA
EMA
Drospirenone, Slynd (discontinued: Drospirenone)
CombinationsAngeliq, Beyaz, Drospirenone ethinyl estradiol, Drospirenone, ethinyl estradiol levomefolate, Lo-zumandimine, Loryna, Melamisa, Nextstellis, Nikki, Safyral, Syeda, Tydemy, Yaela, Yasmin, Yaz, Zumandimine (discontinued: Drospirenone ethinyl estradiol, Kemeya, Kyra)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Drospirenone
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Estetrol
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NEXTSTELLIS | Mayne Group | N-214154 RX | 2021-04-15 | 1 products, RLD, RS |
Drospirenone
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Estradiol
Drospirenone
+
Ethinyl estradiol
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Levomefolate calcium
Drospirenone
+
Ethinyl estradiol
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| angeliq | New Drug Application | 2023-12-08 |
| beyaz | New Drug Application | 2023-05-19 |
| drospirenone and ethinyl estradiol | ANDA | 2024-05-07 |
| drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium | ANDA | 2024-08-12 |
| drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium | NDA authorized generic | 2023-05-19 |
| gianvi | New Drug Application | 2010-11-03 |
| jasmiel | ANDA | 2024-05-14 |
| lo-zumandimine | ANDA | 2023-10-09 |
| loryna | ANDA | 2024-01-10 |
| nextstellis | New Drug Application | 2023-05-11 |
Show 11 more
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DROSPIRENONE / ESTETROL, NEXTSTELLIS, MAYNE PHARMA | |||
| 2026-04-15 | NCE | ||
DROSPIRENONE, DROSPIRENONE, EXELTIS USA INC | |||
| 2025-06-29 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Drospirenone / Estradiol, Angeliq, Bayer Hlthcare | |||
| 8906890 | 2031-10-22 | DP | |
| Drospirenone, Drospirenone, Exeltis Usa Inc | |||
| 9603860 | 2031-06-28 | U-2553 | |
| 10179140 | 2031-06-28 | U-2553 | |
| 10603281 | 2031-06-28 | U-2553 | |
| 10849857 | 2031-06-28 | DP | U-2553 |
| 10987364 | 2031-06-28 | DP | |
| 11123299 | 2031-06-28 | DP | |
| 11291632 | 2031-06-28 | DP | |
| 11291633 | 2031-06-28 | DP | |
| 11351122 | 2031-06-28 | DP | |
| 11413249 | 2031-06-28 | U-2553 | |
| 11439598 | 2031-06-28 | DP | |
| 11478487 | 2031-06-28 | DP | |
| 11504334 | 2031-06-28 | DP | |
| Drospirenone / Ethinyl Estradiol / Levomefolate Calcium, Beyaz, Bayer Hlthcare | |||
| 8617597 | 2030-02-08 | DP | |
| Drospirenone / Estetrol, Nextstellis, Mayne Pharma | |||
| 7732430 | 2025-03-02 | DP | U-3152 |
ATC Codes
G: Genito urinary system and sex hormones
— G03: Sex hormones and modulators of the genital system
— G03A: Hormonal contraceptives for systemic use
— G03AA: Progestogens and estrogen systemic contraceptives, fixed combinations
— G03AA12: Drospirenone and ethinylestradiol
— G03AA18: Drospirenone and estetrol
— G03AC: Progestogen systemic hormonal contraceptives
— G03AC10: Drospirenone
— G03F: Progestogens and estrogens in combination
— G03FA: Progestogens and estrogens, fixed combinations
— G03FA17: Drospirenone and estrogen
HCPCS
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Clinical
Clinical Trials
164 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Contraception | D003267 | — | — | 9 | 4 | 20 | 4 | 14 | 49 |
| Syndrome | D013577 | — | — | 1 | — | 8 | 6 | 8 | 23 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 2 | 1 | 5 | 8 | 5 | 20 |
| Healthy volunteers/patients | — | — | — | 13 | — | 2 | 1 | — | 16 |
| Premenstrual syndrome | D011293 | — | N94.3 | — | 1 | 3 | 2 | 4 | 10 |
| Dysmenorrhea | D004412 | HP_0100607 | N94.6 | — | 2 | 5 | 2 | 3 | 10 |
| Endometriosis | D004715 | EFO_0001065 | N80 | — | 1 | 2 | 3 | 1 | 6 |
| Postmenopause | D017698 | — | — | — | 1 | 2 | 1 | 2 | 6 |
| Premenstrual dysphoric disorder | D065446 | — | F32.81 | — | 2 | 1 | 2 | — | 5 |
| Insulin resistance | D007333 | HP_0000855 | — | — | — | 1 | 2 | — | 3 |
Show 16 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acne vulgaris | D000152 | EFO_0003894 | L70 | — | — | 4 | — | 2 | 6 |
| Hot flashes | D019584 | — | — | — | — | 3 | — | — | 3 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | 1 | — | — | 2 |
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | — | — | 1 | — | — | 1 |
| Dysbiosis | D064806 | — | — | — | — | 1 | — | — | 1 |
| Ovulation inhibition | D034445 | — | — | — | — | 1 | — | — | 1 |
| Neural tube defects | D009436 | HP_0002144 | Q00.0 | — | — | 1 | — | — | 1 |
| Spinal dysraphism | D016135 | EFO_1001210 | Q05 | — | — | 1 | — | — | 1 |
| Essential hypertension | D000075222 | — | I10 | — | — | 1 | — | — | 1 |
| Metrorrhagia | D008796 | HP_0100608 | N92.1 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Depression | D003863 | — | F33.9 | — | 1 | — | — | 2 | 3 |
| Bulimia | D002032 | — | F50.2 | — | 1 | — | — | — | 1 |
| Feeding and eating disorders | D001068 | — | F50 | — | 1 | — | — | — | 1 |
| Bulimia nervosa | D052018 | EFO_0005204 | F50.2 | — | 1 | — | — | — | 1 |
| Binge-eating disorder | D056912 | — | F50.2 | — | 1 | — | — | — | 1 |
| Hidradenitis suppurativa | D017497 | — | L73.2 | — | 1 | — | — | — | 1 |
| Hidradenitis | D016575 | — | — | — | 1 | — | — | — | 1 |
| Hormonal contraception | D000080282 | — | — | — | 1 | — | — | — | 1 |
| Prehypertension | D058246 | — | — | — | 1 | — | — | — | 1 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | 1 | — | — | — | 1 |
Show 1 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adenomyosis | D062788 | EFO_1001757 | N80.0 | 1 | — | — | — | 1 | 2 |
| Area under curve | D019540 | — | — | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Absorption | D000042 | — | — | 1 | — | — | — | — | 1 |
| Infections | D007239 | EFO_0000544 | — | 1 | — | — | — | — | 1 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | — | — | — | — | 1 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 1 | — | — | — | — | 1 |
| Communicable diseases | D003141 | — | — | 1 | — | — | — | — | 1 |
| Biological availability | D001682 | — | — | 1 | — | — | — | — | 1 |
| Overweight | D050177 | — | E66.3 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infertility | D007246 | HP_0000789 | — | — | — | — | — | 2 | 2 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | — | — | — | 2 | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | — | — | 2 | 2 |
| Kallmann syndrome | D017436 | Orphanet_478 | E23.0 | — | — | — | — | 1 | 1 |
| Premature birth | D047928 | EFO_0003917 | O60 | — | — | — | — | 1 | 1 |
| Primary ovarian insufficiency | D016649 | EFO_0004266 | E28.3 | — | — | — | — | 1 | 1 |
| Premature menopause | D008594 | HP_0008209 | E28.31 | — | — | — | — | 1 | 1 |
| Chronic pain | D059350 | HP_0012532 | — | — | — | — | — | 1 | 1 |
| Osteoporosis | D010024 | HP_0000939 | M81.0 | — | — | — | — | 1 | 1 |
| Postmenopausal osteoporosis | D015663 | EFO_0003854 | — | — | — | — | — | 1 | 1 |
Show 6 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Drospirenone |
| INN | drospirenone |
| Description | Drospirenone is a steroid lactone and a 3-oxo-Delta(4) steroid. It has a role as a contraceptive drug, an aldosterone antagonist and a progestin. |
| Classification | Small molecule |
| Drug class | aldosterone antagonists (spironolactone type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@]12CC[C@H]3[C@H]([C@@H]1[C@@H]1C[C@@H]1[C@@]21CCC(=O)O1)[C@H]1C[C@H]1C1=CC(=O)CC[C@@]13C |
Identifiers
| PDB | — |
| CAS-ID | 67392-87-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1509 |
| ChEBI ID | 50838 |
| PubChem CID | 68873 |
| DrugBank | DB01395 |
| UNII ID | N295J34A25 (ChemIDplus, GSRS) |
Target
Agency Approved
NR3C2
NR3C2
Organism
Homo sapiens
Gene name
NR3C2
Gene synonyms
MCR, MLR
NCBI Gene ID
Protein name
mineralocorticoid receptor
Protein synonyms
aldosterone receptor, mineralocorticoid receptor 1, mineralocorticoid receptor 2, mineralocorticoid receptor delta, Nuclear receptor subfamily 3 group C member 2
Uniprot ID
Mouse ortholog
Nr3c2 (110784)
mineralocorticoid receptor (Q8VII8)
Alternate
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Variants
No data
Financial
Revenue by drug
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Estimated US medical usage
Drospirenone
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Estradiol
Total medical expenditures per year (USD, in millions)
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Drospirenone
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Ethinyl estradiol
Total medical expenditures per year (USD, in millions)
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Drospirenone
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Ethinyl estradiol
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Levomefolate
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Angeliq, Beyaz, Drospirenone and ethinyl estradiol, Drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium, Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium, Jasmiel, Lo-zumandimine, Loryna, Nextstellis, Nikki, Ocella, Safyral, Syeda, Tydemy, Vestura, Yasmin, Yaz, Zarah, Zumandimine
Adverse Events
Top Adverse Reactions
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54,670 adverse events reported
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