Overview
Desogestrel, a prodrug, is a third generation progestogen and hence, a member of the gonane family which was largely used in Europe before being approved in the US and Canada. It was firstly generated from a study that showed that 11-beta and 11-alkylidene substituent in nortestosterone can enhance the biological activity. Desogestrel is now produced semi-synthetically from naturally occurred plant steroids. In the US, desogestrel is found only in combination with ethinyl estradiol. The first approved drug containing desogestrel was developed by Organon USA Inc in 1972 and FDA approved in 1992.
Indication
Oral desogestrel is used in combination with ethinylestradiol as a contraceptive agent for the prevention of pregnancy. Desogestrel is part of the combined oral contraceptives that contain a mix of estrogen and progestin which inhibit ovulation.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/03/28 | Phase 4 | Recruiting | |||
2021/12/30 | Not Applicable | Terminated | |||
2021/08/12 | Phase 4 | Completed | |||
2021/06/28 | Phase 2 | Completed | |||
2021/01/28 | Phase 4 | UNKNOWN | Casa di Cura Privata Villa Mafalda | ||
2020/06/09 | Phase 1 | Completed | |||
2019/03/29 | Phase 3 | Completed | |||
2018/01/12 | N/A | Completed | |||
2017/11/28 | N/A | Completed | Institut Universitari Dexeus | ||
2014/04/04 | Phase 3 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| MERCILON TABLET | SIN06136P | TABLET | 0.15 mg | 6/19/1991 |
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 |
|---|---|---|---|---|---|
| BREDICON TABLETS 0.075MG | N/A | N/A | N/A | 11/13/2022 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Desogestrel Ethinylestradiol-DWRN desogestrel 150 microgram and ethinylestradiol 30 microgram tablet blister pack | 426652 | Medicine | A | 3/12/2024 | |
| MADELINE desogestrel 150 microgram and ethinylestradiol 30 microgram tablet blister pack | 202833 | Medicine | A | 9/23/2013 | |
| Desogestrel Ethinylestradiol-RJIC desogestrel 150 microgram and ethinylestradiol 30 microgram tablet blister pack | 426810 | Medicine | A | 3/12/2024 | |
| MARVELON desogestrel / ethinylestradiol 28 tablets | 42894 | Medicine | A | 12/16/1992 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| MARVELON 21 | organon canada inc. | 02042487 | Tablet - Oral | 0.15 MG | 12/31/1993 |
| RECLIPSEN 28 | actavis pharma company | 02417464 | Tablet - Oral | 0.15 MG | 6/29/2014 |
| ORTHO-CEPT TABLETS (28 DAY) | 02042533 | Tablet - Oral | 0.15 MG | 12/31/1993 | |
| FREYA 28 | Mylan Pharmaceuticals ULC | 02396610 | Tablet - Oral | 0.15 MG | 11/22/2012 |
| MILEY 21 | ambicare pharmaceuticals inc. | 02556553 | Tablet - Oral | 0.15 MG | N/A |
| ORTHO-CEPT TABLETS (21 DAY) | 02042541 | Tablet - Oral | 0.15 MG | 12/31/1993 | |
| MARFEM 21 | novopharm limited | 02328828 | Tablet - Oral | 0.15 MG | N/A |
| RECLIPSEN 21 | actavis pharma company | 02420813 | Tablet - Oral | 0.15 MG | 6/29/2014 |
| APRI 28 | teva canada limited | 02317206 | Tablet - Oral | 0.15 MG | 9/29/2008 |
| APRI 21 | teva canada limited | 02317192 | Tablet - Oral | 0.15 MG | 9/29/2008 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| GRACIAL COMPRIMIDOS | 63034 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| DESOGESTREL/ETINILESTRADIOL ARISTO 0,15 MG/0,02 MG COMPRIMIDOS EFG | Aristo Pharma Iberia S.L. | 83128 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| AIDESSIA 0,15 MG/ 0,02 MG COMPRIMIDOS EFG | Laboratorios Cinfa S.A. | 79192 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| DESOGESTREL SANDOZ 75 MICROGRAMOS COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Sandoz Farmaceutica S.A. | 80487 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| CERAZET 75 microgramos COMPRIMIDOS RECUBIERTOS CON PELICULA | Organon Salud S.L. | 62285 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| AIACET 75 MICROGRAMOS COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Cinfa S.A. | 76226 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| BEMASIVE 0,15 MG/0,02 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | BE339412 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| DESOPOP 75 MICROGRAMOS COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Effik S.A. | 76490 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| PILUNA 75 MICROGRAMOS COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 88043 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| DESOGESTREL/ETINILESTRADIOL ARISTO 0,15 MG/0,03 MG COMPRIMIDOS EFG | Aristo Pharma Iberia S.L. | 83129 | COMPRIMIDO | 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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