Etonogestrel

Overview

Etonogestrel molecule is a 3-ketodesogestrel or 19-nortestosterone which is a synthetic biologically active metabolite of progestin desogestrel. The first product including etonogestrel was developed by the Merck subsidiary Organon and FDA approved in 2001.

Indication

Etonogestrel is administered in subdermal implants as long-acting reversible contraception. It is known to be effective in postpartum insertion including breastfeeding women. Etonogestrel is part of the long-acting contraceptive implants that prevent pregnancy. The implant's effect can remain for 5 years.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Body Composition and Sport Performance Among Young Female Soccer Players Using Subdermic Etonogestrel	2025/01/15	NCT06775626	Early Phase 1	Suspended	Maíta Poli de Araújo
The Use of Etonogestrel Contraceptive Implant as Treatment for Endometrial Hyperplasia Without Atypia: A Cohort Study	2024/04/22	NCT06378489	N/A	Not yet recruiting	University of the Philippines
Etonogestrel (ENG) Implant Insertion for Emergency Contraception With Oral Levonorgestrel (LNG) vs Placebo	2023/12/08	NCT06162611	Phase 4	Recruiting	Lori Gawron
Etonogestrel Implants Protect Ovarian Reserve Function in Systemic Lupus Erythematosus	2023/03/30	NCT05791799	Phase 2	Not yet recruiting	Sixth Affiliated Hospital, Sun Yat-sen University
Endometrial Biopsy in Progestin Contraceptive Users	2023/03/08	NCT05760144	Early Phase 1	Recruiting	Oregon Health and Science University
Effects of the Contraceptive Implant in Women With Sickle Cell Disease	2023/02/15	NCT05730205	Phase 4	Recruiting	University of Pennsylvania
Etonogestrel Implant as Emergency Contraception	2022/02/11	NCT05237141	Phase 4	Recruiting	University of Colorado, Denver
Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study	2022/02/07	NCT05227456	Phase 2	Terminated	Saskatchewan Health Authority - Regina Area
Does Oral Desogestrel Prior to Insertion of the Etonogestrel Subdermal Implant Improve Continuation Rate at One Year?	2021/12/30	NCT05174195	Not Applicable	Terminated	University Hospital, Geneva
Pharmacokinetic Interactions of ENG Subdermal Implants with Long-Acting Cabotegravir (CAB-LA) and LA Rilpivirine (RPV-LA) (CARLA)	2021/12/14	NCT05156658	Phase 4	Withdrawn	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
NUVARING	A-S Medication Solutions	50090-5611	VAGINAL	0.12 mg in 1 d	1/9/2023
NUVARING	A-S Medication Solutions	50090-1008	VAGINAL	0.12 mg in 1 d	1/24/2020
NuvaRing	Physicians Total Care, Inc.	54868-4832	VAGINAL	11.7 mg in 1 1	2/9/2012
Etonogestrel/Ethinyl Estradiol	Prasco Laboratories	66993-605	VAGINAL	0.12 mg in 1 d	1/13/2023
Etonogestrel and Ethinyl Estradiol Vaginal	AvKARE	42291-478	VAGINAL	0.12 mg in 1 d	9/21/2023
Etonogestrel and Ethinyl Estradiol Vaginal Ring	Northstar Rx LLC	16714-029	VAGINAL	0.12 mg in 1 d	7/1/2023
NuvaRing	Organon LLC	78206-146	VAGINAL	0.12 mg in 1 d	1/9/2023
Etonogestrel/Ethinyl Estradiol	A-S Medication Solutions	50090-5959	VAGINAL	0.12 mg in 1 d	1/13/2023
Etonogestrel and Ethinyl Estradiol	Teva Pharmaceuticals USA, Inc.	0093-7679	VAGINAL	0.120 mg in 1 d	9/30/2022
NuvaRing	Central Texas Community Health Centers	76413-131	VAGINAL	0.12 mg in 1 d	2/5/2016

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
IMPLANON NXT IMPLANT 68MG	N.V. ORGANON, Synergy Health Ede BV. (Gamma sterilization of finished product), Synergy Health Ede B.V. (Gamma sterilization of finished product)	SIN14086P	IMPLANT	68mg	1/20/2012

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
IMPLANON NXT etonogestrel 68mg subcutaneous implant	358190	ORGANON PHARMA PTY LTD	Medicine	A	5/11/2021
JULESTREL etonogestrel 68mg subcutaneous implant	395527	ORGANON PHARMA PTY LTD	Medicine	A	2/22/2023
LARCPLANON etonogestrel 68mg subcutaneous implant	395528	ORGANON PHARMA PTY LTD	Medicine	A	2/22/2023
NUVARING etonogestrel 11.7 mg and ethinylestradiol 2.7 mg vaginal drug delivery system	381186	ORGANON PHARMA PTY LTD	Medicine	A	3/29/2022

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
HALOETTE	searchlight pharma inc	02520028	Ring (Slow-Release) - Vaginal	11.7 MG	9/29/2021
NEXPLANON	organon canada inc.	02499509	Implant - Subcutaneous	68 MG	8/17/2020
NUVARING	organon canada inc.	02253186	Ring (Slow-Release) - Vaginal	11.4 MG	12/2/2004

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
NUVARING 0,120 mg/0,015 mg CADA 24 HORAS, SISTEMA DE LIBERACION VAGINAL	Organon Salud S.L.	64570	SISTEMA DE LIBERACIÓN VAGINAL	Medicamento Sujeto A Prescripción Médica	Commercialized
DOLNA 0,120 MG/0,015 MG CADA 24 HORAS SISTEMA DE LIBERACION VAGINAL EFG	Laboratorios Cinfa S.A.	82175	SISTEMA DE LIBERACIÓN VAGINAL	Medicamento Sujeto A Prescripción Médica	Commercialized
SETLONA 0,120 MG/0,015 MG CADA 24 HORAS SISTEMA DE LIBERACION VAGINAL EFG	Exeltis Healthcare S.L.	82291	SISTEMA DE LIBERACIÓN VAGINAL	Medicamento Sujeto A Prescripción Médica	Commercialized
MITHRARING 0,120 MG/0,015 MG CADA 24 HORAS SISTEMA DE LIBERACION VAGINAL EFG	Novalon S.A.	84449	SISTEMA DE LIBERACIÓN VAGINAL	Medicamento Sujeto A Prescripción Médica	Not Commercialized
CIRCLET 0,120 mg/0,015 mg CADA 24 HORAS, SISTEMA DE LIBERACION VAGINAL	Organon Salud S.L.	73615	SISTEMA DE LIBERACIÓN VAGINAL	Medicamento Sujeto A Prescripción Médica	Commercialized
NUVARING 0,120 mg/0,015 mg CADA 24 HORAS, SISTEMA DE LIBERACION VAGINAL	Organon Portugal Sociedade Unipessoal Lda.	5717756	SISTEMA DE LIBERACIÓN VAGINAL	Medicamento Sujeto A Prescripción Médica	Commercialized
RINGO 0,120 MG/0,015 MG CADA 24 HORAS, SISTEMA DE LIBERACION VAGINAL EFG	Kern Pharma S.L.	82755	SISTEMA DE LIBERACIÓN VAGINAL	Medicamento Sujeto A Prescripción Médica	Commercialized
IMPLANON NXT 68 mg IMPLANTE	Organon Salud S.L.	62628	IMPLANTE	Diagnóstico Hospitalario	Commercialized
GYNERING 0,120 MG/0,015 MG CADA 24 HORAS SISTEMA DE LIBERACION VAGINAL EFG	Kern Pharma S.L.	83064	SISTEMA DE LIBERACIÓN VAGINAL	Medicamento Sujeto A Prescripción Médica	Not Commercialized
NUVARING 0,120 MG/0,015 MG CADA 24 HORAS SISTEMA DE LIBERACION VAGINAL	Merck Sharp & Dohme Lda.	3694981	SISTEMA DE LIBERACIÓN VAGINAL	Medicamento Sujeto A Prescripción Médica	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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