Overview
A triphenyl ethylene stilbene derivative which is an estrogen agonist or antagonist depending on the target tissue.
Background
A triphenyl ethylene stilbene derivative which is an estrogen agonist or antagonist depending on the target tissue.
Indication
Used mainly in female infertility due to anovulation (e.g. due to polycystic ovary syndrome) to induce ovulation.
Associated Conditions
- Ovulatory Dysfunction
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/22 | Phase 4 | Not yet recruiting | |||
2024/10/10 | Not Applicable | Recruiting | Fundación Santiago Dexeus Font | ||
2024/08/21 | Phase 3 | Completed | Shakeela Ishrat | ||
2023/12/21 | Phase 4 | Completed | |||
2023/05/19 | N/A | Not yet recruiting | Neil Chappell | ||
2023/05/06 | Phase 2 | Completed | |||
2023/03/03 | Phase 4 | Completed | |||
2023/01/27 | Phase 2 | Completed | Services Institute of Medical Sciences, Pakistan | ||
2022/02/09 | Phase 2 | Completed | |||
2022/01/25 | Phase 4 | Active, not recruiting | Rachel Mejia |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bryant Ranch Prepack | 63629-2165 | ORAL | 50 mg in 1 1 | 1/10/2024 | |
| Cosette Pharmaceuticals, Inc. | 0713-0885 | ORAL | 50 mg in 1 1 | 9/23/2022 | |
| Par Pharmaceutical, Inc. | 49884-701 | ORAL | 50 mg in 1 1 | 11/15/2022 | |
| Rebel Distributors Corp | 21695-114 | ORAL | 50 mg in 1 1 | 9/17/2009 | |
| NuCare Pharmaceuticals,Inc. | 68071-2638 | ORAL | 50 mg in 1 1 | 2/4/2022 | |
| A-S Medication Solutions | 50090-6500 | ORAL | 50 mg in 1 1 | 9/23/2022 | |
| NuCare Pharmaceuticals,Inc. | 68071-4676 | ORAL | 50 mg in 1 1 | 2/17/2021 | |
| A-S Medication Solutions | 50090-0677 | ORAL | 50 mg in 1 1 | 3/5/2018 | |
| A-S Medication Solutions | 50090-0678 | ORAL | 50 mg in 1 1 | 11/15/2022 | |
| Myriel Pharmaceuticals LLC | 83390-107 | ORAL | 50 mg in 1 1 | 5/28/2025 |
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 |
|---|---|---|---|---|---|
| DUINUM TABLET 50 mg | SIN04749P | TABLET | 50 mg | 6/22/1990 | |
| SUNOPHENE TABLET 50 mg | SIN03655P | TABLET | 50 mg | 8/15/1989 | |
| OVA-MIT TABLET 50 mg | SIN06399P | TABLET | 50 mg | 7/4/1991 | |
| CLOMIPHENE TABLETS 50 mg | SIN07181P | TABLET | 50 mg | 10/9/1992 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Clomifene Citrate Tablets | codal synto ltd | 国药准字HJ20140688 | 化学药品 | 片剂 | 5/31/2024 |
| Clomifene Citrate Tablets | 国药准字H50020039 | 化学药品 | 片剂 | 8/17/2020 | |
| Clomifene Citrate Tablets | 国药准字H11020546 | 化学药品 | 片剂 | 6/23/2020 | |
| Clomifene Citrate Tablets | 国药准字H13022188 | 化学药品 | 片剂 | 1/15/2021 | |
| Clomifene Citrate Capsules | 国药准字H31021107 | 化学药品 | 胶囊剂 | 10/24/2019 | |
| Clomifene Citrate Capsules | 国药准字H22022100 | 化学药品 | 胶囊剂 | 3/11/2020 | |
| Clomifene Citrate Capsules | 国药准字H44021970 | 化学药品 | 胶囊剂 | 11/13/2019 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| CLONIN CAP 50MG | N/A | N/A | N/A | 7/4/1984 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CLOMID clomifene citrate 50mg tablet blister pack | 313131 | Medicine | A | 8/8/2019 | |
| GENRX CLOMIPHENE clomifene citrate 50mg tablet blister | 78268 | Medicine | A | 7/26/2001 |