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 being studied for bioequivalence. It was evaluated in a Phase 1 clinical trial in healthy, down regulated young women to compare its bioavailability, safety, and tolerability. The drug is not approved and remains in clinical development.
XM17 is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company conducted a Phase 1 study of XM17 to assess its bioavailability, safety, and tolerability in healthy young women.
XM17 is in Phase 1 clinical development. It has completed one Phase 1 trial, which was an active-controlled, randomized study in healthy female volunteers. The drug is investigational and has not been approved by regulatory authorities.
XM17 has one completed clinical trial, identified as NCT02592031. This Phase 1 study compared the bioavailability, safety, and tolerability of XM17 in healthy, down regulated young women. The trial enrolled 49 participants and was active-controlled.
No alternative names for XM17 have been identified. The drug is known by the name XM17 in clinical development. It is being studied for bioequivalence purposes, and no other names have been associated with it in the available information.