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Drug ReportsEstetrol anhydrous
Nextstellis, Drovelis(estetrol)
Drovelis, Lydisilka, Nextstellis (estetrol) is a small molecule pharmaceutical. Estetrol was first approved as Nextstellis on 2021-04-15.
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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
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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
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Commercial
Therapeutic Areas
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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
123 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
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Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ContraceptionD003267——————22
Epidemiology
Epidemiological information for investigational and approved indications
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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:
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Additional graphs summarizing 72,897 documents
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Safety
Black-box Warning
Black-box warning for: Nextstellis
Adverse Events
Top Adverse Reactions
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233 adverse events reported
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