Estetrol - PharmaKB

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

YTD

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

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Commercial

Therapeutic Areas

No data

Trade Name

FDA

EMA

Combinations

Nextstellis

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Drospirenone

Estetrol

Tradename	Company	Number	Date	Products
NEXTSTELLIS	Mayne Group	N-214154 RX	2021-04-15	1 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
nextstellis	New Drug Application	2023-05-11

Indications

FDA

EMA

No data

Agency Specific

FDA

EMA

Expiration	Code
DROSPIRENONE / ESTETROL, NEXTSTELLIS, MAYNE PHARMA
2026-04-15	NCE

Patent Expiration

Patent	Expires	Flag	FDA Information
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

— G03AA18: Drospirenone and estetrol

HCPCS

No data

Clinical

Clinical Trials

112 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Covid-19	D000086382	—	—	—	2	1	1	2	6
Uterine diseases	D014591	—	N85.9	—	—	—	2	—	2
Endometriosis	D004715	EFO_0001065	N80	—	—	—	1	—	1

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Alzheimer disease	D000544	EFO_0000249	F03	1	2	7	—	8	18
Contraception	D003267	—	—	7	2	2	—	2	12
Cognitive dysfunction	D060825	HP_0001268	G31.84	—	2	1	—	6	9
Healthy volunteers/patients	—	—	—	4	1	1	—	—	6
Hot flashes	D019584	—	—	—	1	2	—	—	3
Nerve degeneration	D009410	HP_0002180	—	—	—	1	—	—	1
Hiv infections	D015658	EFO_0000764	B20	—	—	1	—	—	1
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	—	—	1	—	—	1
Immunologic deficiency syndromes	D007153	HP_0002721	D84.9	—	—	1	—	—	1
Chronic renal insufficiency	D051436	—	N18	—	—	1	—	—	1

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Breast neoplasms	D001943	EFO_0003869	C50	3	4	—	—	—	5
Neoplasms	D009369	—	C80	1	3	—	—	2	5
Dementia	D003704	EFO_0003862	F03	—	1	—	—	4	5
Endometrial neoplasms	D016889	EFO_0004230	—	1	1	—	—	1	3
Prostatic neoplasms	D011471	—	C61	1	1	—	—	—	2
Infections	D007239	EFO_0000544	—	—	1	—	—	1	2
Stroke	D020521	EFO_0000712	I63.9	—	1	—	—	1	2
Neoplasm metastasis	D009362	EFO_0009708	—	1	2	—	—	—	2
Triple negative breast neoplasms	D064726	—	—	1	1	—	—	—	1
Vascular system injuries	D057772	—	T14.8	—	1	—	—	—	1

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Menopause	D008593	EFO_0003922	N95	2	—	—	—	—	2
Non-small-cell lung carcinoma	D002289	—	—	1	—	—	—	—	1
Pancreatitis	D010195	HP_0001733	K85	1	—	—	—	—	1
Hypertriglyceridemia	D015228	EFO_0004211	—	1	—	—	—	—	1
Hepatitis c	D006526	—	B19.2	1	—	—	—	—	1
Chronic hepatitis c	D019698	EFO_0004220	B18.2	1	—	—	—	—	1
Hepatitis	D006505	HP_0012115	K75.9	1	—	—	—	—	1
Hepatitis a	D006506	EFO_0007305	B15	1	—	—	—	—	1
Pharmacokinetics	D010599	—	—	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Aging	D000375	GO_0007568	R41.81	—	—	—	—	3	3
Migraine disorders	D008881	EFO_0003821	G43	—	—	—	—	3	3
Syndrome	D013577	—	—	—	—	—	—	2	2
Epilepsy	D004827	EFO_0000474	G40.9	—	—	—	—	2	2
Seizures	D012640	HP_0002069	G40.4	—	—	—	—	2	2
Hemorrhage	D006470	MP_0001914	R58	—	—	—	—	2	2
Atrial fibrillation	D001281	EFO_0000275	I48.0	—	—	—	—	2	2
Bradycardia	D001919	HP_0001662	R00.1	—	—	—	—	2	2
Tachycardia	D013610	HP_0001649	R00.0	—	—	—	—	2	2
Traumatic brain injuries	D000070642	—	S06	—	—	—	—	2	2

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Estetrol
INN	estetrol
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