Approval Probability
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TV-46046 · 2 trials · 1 indication
ISRs were assessed by self-reports and direct observation for each injection at least twice on the day of injection. ISRs included erythema (redness), swelling, pruritus (itching), bleeding, bruising, injection site discoloration (for example, hypopigmentation), or atrophy (that is, dimple).
| Arm | Type | Description |
|---|---|---|
| Group 1 - 120 mg/0.4 mL | EXPERIMENTAL | - |
| Group 2 - 180 mg/0.6 mL | EXPERIMENTAL | - |
| Group 3 - 240 mg/0.8 mL | EXPERIMENTAL | - |
| Group 4 - 104 mg/0.65 mL | ACTIVE_COMPARATOR | - |
| TV-46046 Undiluted | EXPERIMENTAL | Participants will receive TV-46046 undiluted (120 mg/0.3 mL of 400 mg/mL) SC injection as a test formulation in a crossover design with the other 3 SC study drug injections. The 4 study drug injections will be administered approximately 1 hour apart. |
| TV-46046 Diluted | EXPERIMENTAL | Participants will receive TV-46046 saline-diluted (60 mg/0.3 mL of 200 mg/mL) SC injection as a test formulation in a crossover design with the other 3 SC study drug injections. The 4 study drug injections will be administered approximately 1 hour apart. |
| TV-46046 Placebo | PLACEBO_COMPARATOR | Participants will receive TV-46046 placebo (0.3 mL) SC injection in a crossover design with the other 3 SC study drug injections. The 4 study drug injections will be administered approximately 1 hour apart. |
| Depo-subQ 104 | ACTIVE_COMPARATOR | Participants will receive Depo-subQ 104 (medroxyprogesterone acetate injectable suspension; 104 mg/0.65 mL) SC injection as a reference formulation in a crossover design with the other 3 SC study drug injections. The 4 study drug injections will be administered approximately 1 hour apart. |
| Name | Type | Description |
|---|---|---|
| TV-46046 | DRUG | SC injection of 300 mg/mL (120 mg/0.4mL; 180 mg/0.6mL; 240 mg/0.8mL) |
| Depo-subQ Provera | DRUG | SC injection of 104 mg/0.65 mL |
| Depo-subQ 104 | DRUG | Depo-subQ 104 will be administered per dose and schedule specified in the arm. |
| TV-46046 Placebo | DRUG | TV-46046 Placebo will be administered per schedule specified in the arm. |
Inclusion Criteria: * has regular menstrual cycle (21 to 35 days) * has a low risk of pregnancy (ie, sterilized, in exclusively same-sex partnership, abstinent, in monogamous relationship with vasectomized partner, using nonhormonal intrauterine device (IUD), or consistently using barrier methods o...
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.