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.
Background
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 |
|---|---|---|---|---|---|
2025/01/15 | Early Phase 1 | Not yet recruiting | Maíta Poli de Araújo | ||
2024/04/22 | N/A | Not yet recruiting | |||
2023/12/08 | Phase 4 | Recruiting | Lori Gawron | ||
2023/03/30 | Phase 2 | Not yet recruiting | Sixth Affiliated Hospital, Sun Yat-sen University | ||
2023/03/08 | Early Phase 1 | Recruiting | |||
2023/02/15 | Phase 4 | Recruiting | |||
2022/02/11 | Phase 4 | Recruiting | |||
2022/02/07 | Phase 2 | Terminated | Saskatchewan Health Authority - Regina Area | ||
2021/12/30 | Not Applicable | Terminated | |||
2021/12/14 | Phase 4 | Withdrawn | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections |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 |
|---|---|---|---|---|---|
| A-S Medication Solutions | 50090-5611 | VAGINAL | 0.12 mg in 1 d | 1/9/2023 | |
| A-S Medication Solutions | 50090-1008 | VAGINAL | 0.12 mg in 1 d | 1/24/2020 | |
| Physicians Total Care, Inc. | 54868-4832 | VAGINAL | 11.7 mg in 1 1 | 2/9/2012 | |
| Prasco Laboratories | 66993-605 | VAGINAL | 0.12 mg in 1 d | 1/13/2023 | |
| AvKARE | 42291-478 | VAGINAL | 0.12 mg in 1 d | 9/21/2023 | |
| Northstar Rx LLC | 16714-029 | VAGINAL | 0.12 mg in 1 d | 7/1/2023 | |
| Organon LLC | 78206-146 | VAGINAL | 0.12 mg in 1 d | 1/9/2023 | |
| A-S Medication Solutions | 50090-5959 | VAGINAL | 0.12 mg in 1 d | 1/13/2023 | |
| Teva Pharmaceuticals USA, Inc. | 0093-7679 | VAGINAL | 0.120 mg in 1 d | 9/30/2022 | |
| 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 | SIN14086P | IMPLANT | 68mg | 1/20/2012 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Etonogestrel Implants | 国药准字HJ20130884 | 化学药品 | 植入剂 | 7/19/2023 |
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 | Medicine | A | 5/11/2021 | |
| JULESTREL etonogestrel 68mg subcutaneous implant | 395527 | Medicine | A | 2/22/2023 | |
| LARCPLANON etonogestrel 68mg subcutaneous implant | 395528 | Medicine | A | 2/22/2023 | |
| NUVARING etonogestrel 11.7 mg and ethinylestradiol 2.7 mg vaginal drug delivery system | 381186 | Medicine | A | 3/29/2022 |