Yasmin, Lydisilka(drospirenone)
Angeliq, Beyaz, Drovelis, Lydisilka, Nextstellis, Safyral, Slynd, Yasmin, Yaz (drospirenone) is a small molecule pharmaceutical. Drospirenone was first approved as Yasmin on 2001-05-11. It has been approved in Europe to treat contraception. The pharmaceutical is active against mineralocorticoid receptor.
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FDA Novel Drug Approvals 2021
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| therapeutics | D013812 |
Trade Name
FDA
EMA
Slynd (generic drugs available since 2008-05-09)
CombinationsAngeliq, Beyaz, Nextstellis, Safyral, Yasmin, Yaz (generic drugs available since 2008-05-09, discontinued: Kemeya, Kyra)
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 |
|---|---|---|
| angeliq | New Drug Application | 2017-11-14 |
| beyaz | New Drug Application | 2019-01-02 |
| drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium | New Drug Application | 2017-08-08 |
| lo-zumandimine | ANDA | 2021-11-02 |
| loryna | ANDA | 2022-06-09 |
| nextstellis | New Drug Application | 2021-04-14 |
| nikki | ANDA | 2020-07-06 |
| slynd | New Drug Application | 2021-01-19 |
| syeda | ANDA | 2022-06-08 |
| tydemy | ANDA | 2020-11-20 |
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Indications
FDA
EMA
No data
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
No data
Clinical
Clinical Trials
89 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 | 3 | 2 | 12 | 2 | 7 | 26 | ||
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 1 | — | 2 | 5 | 4 | 12 |
| Healthy volunteers/patients | — | 6 | — | 1 | 1 | — | 8 | ||
| Premenstrual syndrome | D011293 | N94.3 | — | 1 | 1 | 1 | 2 | 5 | |
| Postmenopause | D017698 | — | 1 | 1 | 1 | 2 | 5 | ||
| Menstruation disturbances | D008599 | HP_0400007 | N91.5 | — | — | — | 1 | — | 1 |
| Hyperandrogenism | D017588 | — | — | — | 1 | — | 1 | ||
| Body weight changes | D001836 | — | — | — | 1 | — | 1 | ||
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | 1 | — | 1 |
| Pelvic pain | D017699 | — | — | — | 1 | — | 1 |
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 | — | 1 | 5 |
| Premenstrual dysphoric disorder | D065446 | F32.81 | — | 2 | 1 | — | — | 3 | |
| Endometriosis | D004715 | EFO_0001065 | N80 | — | 1 | 1 | — | 1 | 2 |
| Dysmenorrhea | D004412 | HP_0100607 | N94.6 | — | — | 1 | — | 1 | 2 |
| Hot flashes | D019584 | — | — | 2 | — | — | 2 | ||
| Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | 1 | — | — | 2 |
| Ovulation inhibition | D034445 | — | — | 1 | — | — | 1 | ||
| Neural tube defects | D009436 | HP_0002144 | Q00.0 | — | — | 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 | — | — | 1 | 2 | |
| 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 | |
| Prehypertension | D058246 | — | 1 | — | — | — | 1 | ||
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | 1 | — | — | — | — | 1 | |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | — | — | — | — | 1 |
| Biological availability | D001682 | 1 | — | — | — | — | 1 | ||
| Adenomyosis | D062788 | EFO_1001757 | N80.0 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Primary ovarian insufficiency | D016649 | EFO_0004266 | E28.3 | — | — | — | — | 1 | 1 |
| Premature menopause | D008594 | HP_0008209 | E28.31 | — | — | — | — | 1 | 1 |
| Postmenopausal osteoporosis | D015663 | EFO_0003854 | — | — | — | — | 1 | 1 | |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | — | — | — | 1 | 1 |
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 | 11636 |
| 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
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
Black-box warning for: Angeliq, Beyaz, Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium, Lo-zumandimine, Loryna, Nextstellis, Nikki
, Syeda, Tydemy
, Yasmin, Yaz, Zumandimine
Adverse Events
Top Adverse Reactions
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212 adverse events reported
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