Overview
Terconazole is an anti-fungal drug that is mainly used to treat vaginal yeast infections (or vaginal candidiasis). It is classified as a triazole ketal derivative. Terconazole was initially approved by the FDA in 1987. This drug is available in cream and suppository forms and both have demonstrated high levels of safety, efficacy, and tolerability in clinical trials. Due to the existence of 2 stereocentres, there are 4 possible stereoisomers for terconazole.
Background
Terconazole is an anti-fungal drug that is mainly used to treat vaginal yeast infections (or vaginal candidiasis). It is classified as a triazole ketal derivative. Terconazole was initially approved by the FDA in 1987. This drug is available in cream and suppository forms and both have demonstrated high levels of safety, efficacy, and tolerability in clinical trials. Due to the existence of 2 stereocentres, there are 4 possible stereoisomers for terconazole.
Indication
For the treatment of candidiasis (a yeast-like fungal infection) of the vulva and vagina.
Associated Conditions
- Vulvovaginal Candidiasis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2019/12/23 | Not Applicable | UNKNOWN | Hatem AbuHashim | ||
2018/03/22 | Phase 3 | UNKNOWN | |||
2014/12/04 | Phase 3 | Completed | |||
2014/12/04 | Phase 3 | Completed | |||
2014/07/02 | Phase 4 | Completed | Peking University Shenzhen Hospital | ||
2008/12/08 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| H.J. Harkins Company, Inc. | 52959-811 | VAGINAL | 4 mg in 1 g | 1/19/2012 | |
| Bryant Ranch Prepack | 63629-8837 | VAGINAL | 8 mg in 1 g | 9/15/2021 | |
| A-S Medication Solutions | 50090-1196 | VAGINAL | 8 mg in 1 g | 11/7/2019 | |
| Physicians Total Care, Inc. | 54868-5183 | VAGINAL | 8 mg in 1 g | 8/30/2010 | |
| RPK Pharmaceuticals, Inc. | 53002-7240 | VAGINAL | 8 mg in 1 g | 11/7/2019 | |
| A-S Medication Solutions | 50090-6266 | VAGINAL | 4 mg in 1 g | 3/9/2021 | |
| E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0346 | VAGINAL | 4 mg in 1 g | 3/9/2021 | |
| A-S Medication Solutions | 50090-0917 | VAGINAL | 4 mg in 1 g | 11/7/2019 | |
| Cosette Pharmaceuticals, Inc. | 0713-0552 | VAGINAL | 80 mg in 1 1 | 11/23/2022 | |
| A-S Medication Solutions | 50090-1901 | VAGINAL | 8 mg in 1 g | 8/20/2014 |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Terconazole Vaginal Suppositories | 国药准字H20090339 | 化学药品 | 栓剂 | 4/23/2024 |
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||