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Nextstellis, Lydisilka(estetrol)
Drovelis, Lydisilka, Nextstellis (estetrol) is a small molecule pharmaceutical. Estetrol was first approved as Nextstellis on 2021-04-15. It has been approved in Europe to treat contraception.
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FDA Novel Drug Approvals 2021
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
therapeuticsD013812
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 Application2021-04-14
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
14 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hot flashesD019584—12——3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471C6111———2
Healthy volunteers/patients—11———2
ContraceptionD00326711———2
Breast neoplasmsD001943EFO_0003869C5012———2
Covid-19D000086382U07.1—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MenopauseD008593EFO_0003922N951————1
Indications Without Phase
No data
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)
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
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 275 documents
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Safety
Black-box Warning
Black-box warning for: Nextstellis
Adverse Events
Top Adverse Reactions
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51,446 adverse events reported
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