PharmaKB logo
Company Reports
Company Reports
Drug Reports
Drug Reports
Disease Reports
Disease Reports
Sets
Sets
Favorites
Favorites
Log in
Log in
AboutPricing
Drug ReportsEstetrol
Nextstellis, Lydisilka(estetrol)
Drovelis, Lydisilka, Nextstellis (estetrol) is a small molecule pharmaceutical. Estetrol was first approved as Nextstellis on 2021-04-15.
Download report
Favorite
FDA Novel Drug Approvals 2021
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
Plot placeholder
Mock data
Subscribe for the real data
Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Combinations
Nextstellis
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Drospirenone
+
Estetrol
Tradename
Company
Number
Date
Products
NEXTSTELLISMayne GroupN-214154 RX2021-04-15
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
nextstellisNew Drug Application2023-05-11
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
DROSPIRENONE / ESTETROL, NEXTSTELLIS, MAYNE PHARMA
2026-04-15NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Drospirenone / Estetrol, Nextstellis, Mayne Pharma
77324302025-03-02DPU-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
— G03AA18: Drospirenone and estetrol
HCPCS
No data
Clinical
Clinical Trials
31 clinical trials
View more details
Plot placeholder
Mock data
Subscribe for the real data
Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ContraceptionD003267——722—212
Hot flashesD019584———12——3
Healthy volunteers/patients———111——3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471—C6111———2
Breast neoplasmsD001943EFO_0003869C5012———2
Covid-19D000086382—U07.1—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MenopauseD008593EFO_0003922N952————2
PharmacokineticsD010599——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
Drug common nameEstetrol
INNestetrol
Description
Estetrol is a 3-hydroxy steroid that is 17beta-estradiol which has been substituted at the 15alpha and 16alpha positions by two additional hydroxy groups. It is a natural estrogen produced exclusively during pregnancy by the fetal liver. It has a role as an estrogen, an estrogen receptor agonist, a human metabolite, a human xenobiotic metabolite and an oral contraceptive. It is a 3-hydroxy steroid, a 17beta-hydroxy steroid, a 16alpha-hydroxy steroid, a 15alpha-hydroxy steroid and a steroid hormone. It derives from a hydride of an estrane.
Classification
Small molecule
Drug class-
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
C[C@]12CC[C@@H]3c4ccc(O)cc4CC[C@H]3[C@@H]1[C@@H](O)[C@@H](O)[C@@H]2O
Identifiers
PDB—
CAS-ID15183-37-6
RxCUI—
ChEMBL IDCHEMBL1230314
ChEBI ID—
PubChem CID27125
DrugBankDB12235
UNII IDENB39R14VF (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Plot placeholder
Mock data
Subscribe for the real data
Additional graphs summarizing 64,370 documents
View more details
Safety
Black-box Warning
Black-box warning for: Nextstellis
Adverse Events
Top Adverse Reactions
Plot placeholder
Mock data
Subscribe for the real data
96 adverse events reported
View more details
© 2020-2024 Collaborative Drug Discovery Inc. (CDD) | Terms of Use