Phuturdex › Drugs › Ligufalimab
Drugs in development · updated 13 November 2026
Ligufalimab: clinical trials and development status
Other names and codes: AK117
As of 13 November 2026 Ligufalimab is in 14 active clinical trials (recruiting or ongoing, phases I–III) for 10 diseases. The most advanced phase is III.
Authorisation
- EU no (EMA)
- Italy not in the AIFA register
- Germany not available
- US no (FDA)
Sources: EMA, AIFA register (open data), FDA. For Germany only the EU centralised authorisation is shown: the national BfArM register is not one of our sources.
Map of sites in Europe with recruitment status, every trial and an email when something changes. Full access free until 31 March 2027, no card needed.
What it is
A humanized immunoglobulin G4 (IgG4) monoclonal antibody targeting leukocyte surface antigen CD47, with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, ligufalimab targets and binds to CD47 expressed on tumor cells, blocking the interaction of CD47 with signal regulatory protein alpha (SIRPa) expressed on phagocytic cells. This prevents CD47/SIRPa-mediated signaling and abrogates the CD47/SIRPa-mediated inhibition of macrophage activation and phagocytosis of cancer cells. This induces pro-phagocytic signaling mediated by the binding of calreticulin (CRT), which is specifically expressed on the surface of tumor cells, to low-density lipoprotein (LDL) receptor-related protein-1 (LRP-1), which is expressed on macrophages, and results in macrophage activation and the specific phagocytosis of tumor cells. CD47, also called integrin-associated protein (IAP), is a tumor-associated antigen (TAA) expressed on normal, healthy hematopoietic stem cells (HSCs) and overexpressed on the surface of a variety of cancer cells.
Diseases studied
For each disease: the drug’s most advanced phase and active trials, with the reference trial on ClinicalTrials.gov.
| Disease | Most advanced phase | Active trials | Reference trial |
|---|---|---|---|
| Head and neck squamous cell carcinoma | III | 2 | NCT07264075 |
| Head and neck neoplasms | III | 1 | NCT07264075 |
| Pancreatic neoplasm | III | 1 | NCT06953999 |
| Acute myeloid leukemia | I–II | 2 | NCT04980885 |
| Biliary tract neoplasm | II | 1 | NCT06789848 |
| Colorectal neoplasm | II | 1 | NCT05382442 |
| Hepatocellular carcinoma | II | 1 | NCT06789848 |
| Lung small cell carcinoma | II | 1 | NCT07245446 |
| Myelodysplastic Syndromes | I–II | 1 | NCT04900350 |
| Triple-negative breast neoplasm | II | 1 | NCT05227664 |
Sites in Europe
1 site of the active trials in France.
- France1
Sites declared by the sponsors on ClinicalTrials.gov; region worked out by Phuturdex from the geographic point. The list of sites with city and recruitment status is in the app. See the sites →
Everything on Ligufalimab
In Phuturdex you get every trial with sponsors, countries and dates, development events, FDA and EMA approvals, patents and exclusivities, orphan designations and safety alerts, with PDF and Excel export. Free until 31 March 2027.
Open in Phuturdex →Source: Phuturdex analysis of ClinicalTrials.gov (U.S. National Library of Medicine), FDA and EMA data, updated 13 November 2026. Active trials = recruiting or ongoing, phases I–III. Diseases are those named by each trial (NLM MeSH terms). The estimated launch, when shown, refers to the United States and is a Phuturdex calculation described on the Method page, not official data: the drug may already be marketed in other countries.