Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ZL-1109 (VRDN-003)
ZL-1109 · 1 trial · 1 indication
Proportion of participants with a ≥2 mm reduction from baseline in proptosis in the study eye \[without a corresponding increase of ≥2 mm in the fellow eye\]
| Arm | Type | Description |
|---|---|---|
| Randomized controlled period: ZL-1109 every 4 weeks | EXPERIMENTAL | Participants will receive ZL-1109 per protocol defined dosing regimen. |
| Randomized controlled period: ZL-1109 every 8 weeks | EXPERIMENTAL | Participants will receive ZL-1109 and placebo per protocol defined dosing regimen. |
| Randomized controlled period: Placebo every 4 weeks | PLACEBO_COMPARATOR | Participants will receive placebo per protocol defined dosing regimen. |
| OLE treatment period: ZL-1109 every 4 weeks | OTHER | Participants who not responded would receive ZL-1109 per protocol defined dosing regimen. |
| Name | Type | Description |
|---|---|---|
| ZL-1109 (VRDN-003) | DRUG | ZL-1109 subcutaneous injection |
| Placebo | DRUG | Matching placebo subcutaneous injection |
Key Inclusion Criteria: 1. Have moderate to severe TED 2. Must meet the clinical diagnosis criteria of active TED 3. Must agree to use highly effective contraception as specified in the protocol 4. Female TED participants must have a negative serum pregnancy test at screening Key Exclusion Criteri...
ZL-1109 is an investigational small molecule being developed for the treatment of Thyroid Eye Disease (TED), a condition affecting the tissues around the eyes. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
ZL-1109 is being developed by Zai Lab Limited, a biopharmaceutical company listed on the NASDAQ under the ticker symbol ZLAB. The company is conducting clinical trials for this investigational drug in China.
ZL-1109 is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities for the treatment of Thyroid Eye Disease. The ongoing Phase 3 trial is currently recruiting participants.
ZL-1109 is being evaluated in a Phase 3 clinical trial with the identifier NCT07211776. This randomized, double-blind, placebo-controlled study is assessing the efficacy and safety of ZL-1109 in Chinese participants with active Thyroid Eye Disease. The trial is currently recruiting and aims to enroll 99 participants.
Yes, ZL-1109 is also known as VRDN-003. Both names refer to the same investigational drug being developed by Zai Lab Limited for the treatment of Thyroid Eye Disease.