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Drugs in development · updated 11 November 2026
Tifcemalimab: clinical trials and development status
Other names and codes: JS004
As of 11 November 2026 Tifcemalimab is in 7 active clinical trials (recruiting or ongoing, phases I–III) for 6 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 recombinant humanized immunoglobulin G4 kappa (IgG4k) monoclonal antibody directed against B- and T-lymphocyte attenuator (BTLA), with potential immunomodulating and antineoplastic activities. Upon intravenous infusion administration, tifcemalimab targets and binds to BTLA. This prevents BTLA-mediated inhibition of T-cell activation leading to antigen specific T-cell proliferation and activation of a cytotoxic T-lymphocyte (CTL)-mediated immune response against tumor cells. BTLA, an immunoglobulin (Ig) receptor family member expressed on activated T- and B- lymphocytes, subsets of dendritic cells (DCs), macrophages, and nature killer (NK) cells, is an immune checkpoint involved in suppressing immune responses. It mediates inhibition of human tumor-specific CTLs upon engagement by tumor expressed herpesvirus-entry mediator (HVEM).
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 |
|---|---|---|---|
| Lung small cell carcinoma | III | 2 | NCT06095583 |
| Hodgkin lymphoma | III | 1 | NCT06170489 |
| Non-small-cell lung carcinoma | II | 1 | NCT05891080 |
| Pancreatic neoplasm | I–II | 1 | NCT06370754 |
| Renal cell carcinoma | II | 1 | NCT06690697 |
| Triple-negative breast neoplasm | II | 1 | NCT07101614 |
Sites in Europe
13 sites of the active trials in 2 European countries, 1 recruiting.
- Spain9
- Netherlands4
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 Tifcemalimab
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 11 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.