Phuturdex › Drugs › Garetatug rezetecan
Drugs in development · updated 11 November 2026
Garetatug rezetecan: clinical trials and development status
Other names and codes: SHR-A1904
As of 11 November 2026 Garetatug rezetecan is in 10 active clinical trials (recruiting or ongoing, phases I–III) for 2 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
An antibody-drug conjugate (ADC) composed of garetatug, an immunoglobulin G1 (IgG1) monoclonal antibody directed against the tumor-associated antigen (TAA) Claudin 18.2 (CLDN18.2; A2 isoform of claudin-18) conjugated, via a cleavable linker, to rezetecan, an exatecan derivative and topoisomerase 1 inhibitor, with potential antineoplastic activity. Upon administration of garetatug rezetecan, the anti-CLDN18.2 monoclonal antibody moiety specifically targets and binds to CLDN18.2 expressed on tumor cells. Upon binding, internalization and linker cleavage, rezetecan is released and inhibits DNA topoisomerase I activity, thereby inhibiting DNA replication and resulting in cell cycle arrest and apoptosis in tumor cells expressing CLDN18.2. CLDN18.2, a tight junction protein and stomach-specific isoform of claudin-18, is expressed on a variety of tumor cells. Its expression in healthy tissues is strictly confined to short-lived differentiated epithelial cells of the gastric mucosa.
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 |
|---|---|---|---|
| Stomach neoplasm | II | 3 | NCT07110571 |
| Biliary tract neoplasm | II | 1 | NCT07450976 |
Everything on Garetatug rezetecan
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.