Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
XM17 · 1 trial · 1 indication
XM17 and Gonal-f® tested statistically for bioequivalence.
XM17 and Gonal-f® tested statistically for bioequivalence.
| Arm | Type | Description |
|---|---|---|
| XM17 | EXPERIMENTAL | XM17 will be administered by 1 mL syringes in graduated steps of 0.01 mL. |
| Gonal-f® | EXPERIMENTAL | Gonal-f® will be provided in pens with integrated vials of 0.5 mL |
| Zoladex® | ACTIVE_COMPARATOR | Zoladex® 3.6 mg will be administered by subcutaneous injection |
| Name | Type | Description |
|---|---|---|
| XM17 | DRUG | 300 IU corresponds to an injection volume of 0.5 mL. |
| Gonal-f® | DRUG | 300 IU corresponds to an injection volume of 0.5 mL. |
| Zoladex® | DRUG | 3.6 mg |
Inclusion Criteria: * Having signed written informed consent * Healthy female subjects of any racial origin * 18-39 years at the time of screening * Body mass index (BMI) between 18-29 kg/m2 and a body weight of ≥ 50 kg * Use of oral contraceptives for contraceptive purposes only and not for regula...
XM17 is an investigational small molecule developed by Teva Pharmaceutical Industries Limited. It has been studied in a Phase 1 clinical trial in healthy young women. The specific therapeutic indication for XM17 has not been disclosed, and the compound remains in early clinical development.
XM17 is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the clinical program evaluating the compound. The drug remains investigational and has not been approved for any indication.
XM17 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound is investigational and has not received FDA approval for any indication.
XM17 has been evaluated in one completed Phase 1 trial, NCT02592031, titled a study to compare the bioavailability, safety and tolerability of XM17 in healthy, down regulated young women. The trial enrolled 49 participants, was randomized, and used an active-controlled design.
The completed Phase 1 trial NCT02592031 evaluated the bioavailability, safety and tolerability of XM17 in healthy young women. It enrolled 49 participants, was randomized, and used an active-controlled design. Participants were female, aged 18 years and older, and were healthy volunteers.