Product Description
Aldafermin is an engineered analog of the human hormone FGF19 that is dosed once daily as a subcutaneous injection.
Mechanisms of Action: FGFR Agonist
Novel Mechanism: No
Modality: Peptide/Protein
Route of Administration: Subcutaneous
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Company: Atlas Neon Parent
Company Location: Western America
Company Founding Year: None
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
- Clinical Outcomes Reported - NGM presented P2 Non-alcoholic Steatohepatitis results on 2023-11-13 for Aldafermin
Highest Development Phases
Phase 3: Cholangitis, Sclerosing
Phase 2: Liver Cirrhosis|Biliary Cirrhosis|Constipation|Hepatitis, Alcoholic|Metabolic Dysfunction-Associated Steatohepatitis|Type 2 Diabetes|Diarrhea|Liver Cirrhosis, Alcoholic|Fatty Liver, Alcoholic|Cholangitis, Sclerosing|Irritable Bowel Syndrome|Malabsorption Syndromes
Phase 1: Other|General Diabetes|Healthy Volunteers|Kidney Diseases
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04210245 |
ALPINE 4 | P2 |
Completed |
Metabolic Dysfunction-Associated Steatohepatitis|Hepatitis, Alcoholic|Fatty Liver, Alcoholic|Liver Cirrhosis, Alcoholic |
2023-01-04 |
41% |
2023-06-14 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT04828265 |
282-HV-105 | P1 |
Completed |
Healthy Volunteers |
2021-07-06 |
50% |
2022-02-02 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
NCT04179630 |
282-RI-103 | P1 |
Completed |
Kidney Diseases |
2019-12-04 |
12% |
2020-04-28 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT01776528 |
NCT01776528 | P1 |
Completed |
General Diabetes|Healthy Volunteers |
2013-07-01 |
2019-03-19 |
||
NCT05130047 |
NCT05130047 | P2 |
Completed |
Malabsorption Syndromes|Diarrhea|Irritable Bowel Syndrome |
2022-11-08 |
12% |
2023-10-13 |
Patient Enrollment|Primary Endpoints|Study Completion Date|Treatments |
2019-002341-38 |
ALPINE 4 | P2 |
Unknown status |
Liver Cirrhosis|Hepatitis, Alcoholic|Metabolic Dysfunction-Associated Steatohepatitis |
2022-07-02 |
2022-03-13 |
Treatments |
|
NCT03912532 |
ALPINE 2/3 | P2 |
Completed |
Hepatitis, Alcoholic|Fatty Liver, Alcoholic|Metabolic Dysfunction-Associated Steatohepatitis |
2021-03-04 |
48% |
2022-01-07 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
NCT02443116 |
NCT02443116 | P2 |
Completed |
Hepatitis, Alcoholic|Fatty Liver, Alcoholic|Metabolic Dysfunction-Associated Steatohepatitis |
2019-12-06 |
65% |
2020-09-16 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
2015-003392-30 |
2015-003392-30 | P2 |
Completed |
Cholangitis, Sclerosing |
2017-06-07 |
2025-07-01 |
Treatments |
|
NCT02704364 |
NCT02704364 | P2 |
Completed |
Cholangitis, Sclerosing |
2017-06-01 |
2019-03-20 |
||
NCT02649062 |
NCT02649062 | P2 |
Completed |
Constipation |
2017-01-01 |
2019-03-20 |
Treatments |
|
NCT02135536 |
NCT02135536 | P2 |
Completed |
Biliary Cirrhosis|Liver Cirrhosis |
2016-02-01 |
2019-03-20 |
Treatments |
|
NCT02026401 |
NCT02026401 | P2 |
Completed |
Liver Cirrhosis|Biliary Cirrhosis |
2014-12-01 |
2019-03-20 |
Treatments |
|
NCT01943045 |
NCT01943045 | P2 |
Completed |
Type 2 Diabetes |
2014-09-01 |
2019-03-20 |
Treatments |
|
NCT04823702 |
282-HI-104 | P1 |
Completed |
Other |
2021-11-19 |
12% |
2022-01-20 |
|
NCT06654726 |
ALPINE-PSC | P3 |
Withdrawn |
Cholangitis, Sclerosing |
2024-12-05 |
45% |
2025-05-08 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |