Product Description
ALLN-346 is an investigational, orally administered, novel urate-degrading enzyme that has been designed for activity and stability in the gastrointestinal (GI) tract, and is intended for the treatment of hyperuricemia in patients with gout and advanced chronic kidney disease (CKD).
Mechanisms of Action: Uric Acid Degrader
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Fast Track - Gout|Kidney Diseases *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Company: Allena
Company Location:
Company Founding Year: None
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 2: Kidney Failure, Chronic
Phase 1: Gout|Inflammation
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT05168683 |
ALLN-346-103 | P1 |
Completed |
Gout |
2022-02-23 |
2023-01-25 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
|
NCT04829435 |
MAD | P1 |
Completed |
Gout |
2021-06-01 |
2021-07-02 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
|
NCT04236219 |
SAD | P1 |
Completed |
Inflammation |
2020-11-06 |
2021-07-24 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
|
NCT04987294 |
ALLN-346-202 | P2 |
Terminated |
Kidney Failure, Chronic |
2022-09-02 |
2023-06-24 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
|
NCT04987242 |
Study 201 | P2 |
Completed |
Kidney Failure, Chronic |
2022-03-02 |
2023-06-24 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |