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TV-46046-mL · 1 trial · 2 indications
'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Ovulation was defined as a single elevated serum progesterone ≥4.7 ng/mL.
| Arm | Type | Description |
|---|---|---|
| TV-46046 - 1 | EXPERIMENTAL | - |
| TV-46046 - 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| TV-46046 - 400 mg/mL | DRUG | A single subcutaneous injection in the abdomen of undiluted TV-46046 - 400 mg/mL |
| TV-46046 - 200 mg/mL | DRUG | A single subcutaneous injection in the abdomen of saline-diluted TV-46046 - 200 mg/mL |
Inclusion Criteria: * has regular menstrual cycle (24 to 35 days) * is at low risk of pregnancy (ie, sterilized, in exclusively same-sex partnership, in monogamous relationship with vasectomized partner, or using non-hormonal IUD) * is in good general health as determined by a medical history and p...
TV-46046 is an investigational small molecule being developed for contraception and pregnancy prevention. It is a long-acting injectable formulation of medroxyprogesterone acetate intended for use in women of reproductive age. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
TV-46046 is being developed by Teva Pharmaceutical Industries Limited, a company publicly traded under the ticker symbol TEVA. The drug is an investigational product candidate in the company's endocrine therapeutic area pipeline, focused on women's reproductive health and contraception.
TV-46046 is in Phase 1 clinical development. Three Phase 1 trials have been completed, with a total of 87 participants enrolled across studies conducted in the United States and the Dominican Republic. The drug remains investigational and has not received regulatory approval for any indication.
TV-46046 has completed three Phase 1 clinical trials: NCT02817464 evaluated suppression of ovulation and pharmacokinetics in 12 women with ovulatory cycles; NCT03700658 assessed injection pain and local tolerability in 27 women; and NCT04682353 studied pharmacokinetics in 60 healthy women of reproductive age. All trials were completed.
TV-46046 is a small molecule formulation of medroxyprogesterone acetate, a progestin hormone. It works by delivering a sustained release of medroxyprogesterone acetate to suppress ovulation, thereby preventing pregnancy. The drug is administered via subcutaneous injection to provide long-acting contraceptive effects.
TV-46046 is a proprietary long-acting injectable formulation of medroxyprogesterone acetate, not the same as standard immediate-release versions. It is designed to provide sustained drug release over an extended period. The active pharmaceutical ingredient is medroxyprogesterone acetate, but TV-46046 is a distinct product candidate in development.