> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/loncastuximab-tesirine-a37d802c-da76-404a-83d2-de625c048f90 > Record changed: 2026-10-13 # Loncastuximab tesirine Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297778) Drug type Antibody drug conjugate Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297778) First approval year 2021 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297778) ## Development status **First approval year** 2021 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297778) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297778) ## Names and chemistry **Drug type** Antibody drug conjugate Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297778) **Drug name** Loncastuximab tesirine Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297778) ### Brand names (2) - zynlonta - Zynlonta ### Other names (23) - adct 402 - adct 402 tesirine - ADCT-402 - Adct-402 tesirine - ADCT-402 TESIRINE - loncastuximab tesirina - Loncastuximab tesirina - loncastuximab tesirine - Loncastuximab tesirine - Loncastuximab Tesirine - loncastuximab tesirine \[INN\] - Loncastuximab tesirine \[MI\] - LONCASTUXIMAB TESIRINE \[USAN\] - Loncastuximab tesirine \[WHO-DD\] - loncastuximab tesirine inn - loncastuximab tesirine lpyl - Loncastuximab tesirine lpyl - Loncastuximab tesirine lpyl \[WHO-DD\] - loncastuximab tesirine lpyl who dd - loncastuximab tesirine mi - loncastuximab tesirine usan - loncastuximab tesirine who dd - Loncastuximab tesirine-lpyl ## Identifiers **ATC classification codes** - L01FX22 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297778) **CAS registry numbers** - 1879918-31-6 **ChEMBL ID** CHEMBL4297778 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297778) **FDA ingredient codes (UNII)** - 7K5O7P6QIU ### RxNorm IDs (RxCUI) (2) - 2540964 - 2540965 ## Regulatory information ### United States **Applicant** ADC Therapeutics SA **Approval date** 23 Apr 2021 **Application number** BLA761196 ### European Union **Status** Authorised **Status date** 20 Dec 2022 **Authorisation date** 20 Dec 2022 **Approved indications** Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy. **Product number** EMEA/H/C/005685 **Authorisation holder** Swedish Orphan Biovitrum AB **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** Yes **Additional monitoring** Yes **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Lymphoma, B-Cell - Lymphoma, Large B-Cell, Diffuse European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/zynlonta) ### Other regulatory facts **Patents** 0 **Designations** 3 **Earliest recorded loss of exclusivity** 23 Apr 2028 **First in class** Yes **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** Yes **Orphan exclusivity** No **Accelerated approval** Yes **Availability** Prescription only ## Pharmacology ### Drug classification **Pharmacology name** loncastuximab tesirine **Type** Antibody **Drug name stem** \-mab **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Parenteral ### Mechanisms of action (3) - **Mechanism** B-lymphocyte antigen CD19 binding agent **Action type** BINDING\_AGENT **Target** B-lymphocyte antigen CD19 **Protein identifier** P15391 - **Action** Binding **Action type** Binding **Target** CD19 **Gene symbol** CD19 **Protein identifier** P15391 - **Mechanism** DNA cross-linking agent **Action type** CROSS\_LINKING\_AGENT **Target** DNA ### Open Targets mechanisms - **Mechanism** B-lymphocyte antigen CD19 binding agent **Action type** BINDING AGENT **Target** B-lymphocyte antigen CD19 ### Investigated indications (12) - **Condition** Leukemia, Lymphocytic, Chronic, B-Cell **Highest recorded phase** 1 **Condition identifier** EFO:0000095 **Subject identifier** D015451 - **Condition** Lymphoma, Follicular **Highest recorded phase** 2 **Condition identifier** EFO:0000096 **Subject identifier** D008224 - **Condition** Precursor Cell Lymphoblastic Leukemia-Lymphoma **Highest recorded phase** 1 **Condition identifier** EFO:0000220 **Subject identifier** D054198 - **Condition** Burkitt Lymphoma **Highest recorded phase** 1 **Condition identifier** EFO:0000309 **Subject identifier** D002051 - **Condition** Lymphoma, Large B-Cell, Diffuse **Highest recorded phase** 4 **Condition identifier** EFO:0000403 **Subject identifier** D016403 - **Condition** Neoplasms **Highest recorded phase** 4 **Condition identifier** EFO:0000616 **Subject identifier** D009369 - **Condition** Lymphoma, Non-Hodgkin **Highest recorded phase** 2 **Condition identifier** EFO:0005952 **Subject identifier** D008228 - **Condition** Waldenstrom Macroglobulinemia **Highest recorded phase** 2 **Condition identifier** EFO:0009441 **Subject identifier** D008258 - **Condition** Lymphoma, Mantle-Cell **Highest recorded phase** 2 **Condition identifier** EFO:1001469 **Subject identifier** D020522 - **Condition** Lymphoma, B-Cell **Highest recorded phase** 4 **Condition identifier** EFO:1001938 **Subject identifier** D016393 - **Condition** Lymphoma, B-Cell **Highest recorded phase** 4 **Condition identifier** MONDO:0004095 **Subject identifier** D016393 - **Condition** Lymphoma, Follicular **Highest recorded phase** 2 **Condition identifier** MONDO:0018906 **Subject identifier** D008224 ### Open Targets indications (24) - **Condition identifier** EFO\_0000095 **Highest recorded phase** 1 - **Condition identifier** EFO\_0000096 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000220 **Highest recorded phase** 1 - **Condition identifier** EFO\_0000403 - **Condition identifier** EFO\_0000616 - **Condition identifier** EFO\_0005952 **Highest recorded phase** 1 - **Condition identifier** EFO\_1001938 - **Condition identifier** MONDO\_0002571 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0004095 - **Condition identifier** MONDO\_0004095 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0004948 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0004967 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005062 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005070 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0007243 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0015759 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0017604 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0018876 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0018905 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0018906 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0018908 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0019088 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0044889 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0100280 **Highest recorded phase** 2 ### Trial references (16) - NCT02669264 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02669264) - NCT03589469 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03589469) - NCT04384484 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04384484) - NCT04974996 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04974996) - NCT05144009 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144009) - NCT05222438 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05222438) - NCT05464719 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464719) - NCT04970901 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04970901) - NCT05270057 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05270057) - NCT04699461 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04699461) - NCT04998669 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04998669) - NCT05053659 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05053659) - NCT05991388 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05991388) - NCT05190705 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05190705) - NCT05249959 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05249959) - NCT05971251 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05971251) ## Dosing **Dose** 0.15 mg/kg **Route** Intravenous **How often** Every 3 weeks ### Conditions of use (3) - Administer as an infusion over 30 minutes. - Do not mix with or administer with other drugs. - Premedicate with dexamethasone 4 mg orally or intravenously twice daily for 3 days starting the day before ZYNLONTA. ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ### Sequences (3) - **Component** Heavy chain **Type** Protein **Sequence** QVQLVQPGAEVVKPGASVKLSCKTSGYTFTSNWMHWVKQAPGQGLEWIGEIDPSDSYTNYNQNFQGKAKLTVDKSTSTAYMEVSSLRSDDTAVYYCARGSNPYYYAMDYWGQGTSVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPG - **Component** Light chain **Type** Protein **Sequence** EIVLTQSPAIMSASPGERVTMTCSASSGVNYMHWYQQKPGTSPRRWIYDTSKLASGVPARFSGSGSGTSYSLTISSMEPEDAATYYCHQRGSYTFGGGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC1 - **Component** Disulfide bridges location **Sequence** 22-96$22''-96''$23'-87'$23'''-87'''$131'-191'$131'''-191'''$147-203$147''-203''$211'-223$211'''-223''$229-229''$232-232''$264-324$264''-324''$370-428$370''-428'' ## National Drug Codes - 79952-110 ## Related records ### Trials (30) - A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma - A Phase II Study of Loncastuximab Tesirine as Consolidation Strategy in Patients With LBCL in PR After CAR T-cell Therapy - A Study of Loncastuximab Tesirine and Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Participants With Diffuse Large B-cell Lymphoma (DLBCL) - A Study to Evaluate the Pharmacokinetics and Safety of Loncastuximab Tesirine in Participants With Relapsed or Refractory Diffuse Large B-cell Lymphoma or High-grade B-cell Lymphoma With Hepatic Impairment (LOTIS-10) - [A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)](https://trialight.com/data/trial/a-study-to-evaluate-the-safety-and-anti-cancer-activity-of-d4edad9b-3a59-455e-8286-6a729b1db7e2.md) - A Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of Loncastuximab Tesirine in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated Diffuse Large B-cell Lymphoma (LOTIS-8) - Addition of Loncastuximab Tesirine to Acalbrutinib , Chronic Lymphocytic Leukemia - Combining Loncastuximab Tesirine and Epcoritamab in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) - Consolidation With Loncastuximab Tesirine After a Short Course of Immunochemotherapy in BTKi-treated (or Intolerant) Relapsed/Refractory Mantle Cell Lymphoma Patients. - Epcoritamab in Combination With Loncastuximab Tesirine in Relapsed/Refractory Large B-cell Lymphoma - Loncastixumab Tesirine (ADCT-402) Expanded Access Program (EAP) for Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma - Loncastuximab Tesirine and Mosunetuzumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma - Loncastuximab Tesirine and Rituximab as Bridging Therapy Before Standard-of-care CAR-T Therapy in Patients With Large B-cell Lymphoma (CORAL) - Loncastuximab Tesirine and Rituximab as First-line Therapy in Patients With Post-transplant Lymphoproliferative Disorder (PLUTO) - Loncastuximab Tesirine and Rituximab Followed by DA-EPOCH-R for Treating Patients With High-Risk Diffuse Large B-cell Lymphoma - Loncastuximab Tesirine and Rituximab Following Stereotactic Radiosurgery in Patients With Central Nervous System Lymphomas (SOLAR) - Loncastuximab Tesirine and Venetoclax for Relapsed/ Refractory Non-Hodgkin Lymphoma - Loncastuximab Tesirine for the Treatment of Relapsed or Refractory B-Cell Malignancies - Loncastuximab Tesirine in Combination With Chemotherapy Prior to Stem Cell Transplant for the Treatment of Recurrent or Refractory Diffuse Large B-Cell Lymphoma - Loncastuximab Tesirine in Combination With DA-EPOCH-R in Patients With Previously Untreated Aggressive B-cell Lymphoid Malignancies ### Approved for (4) - [B-cell neoplasm](https://trialight.com/data/condition/b-cell-neoplasm-ffd0710d-7dbd-55bc-a4a5-3c1cf532bac2.md) - [B-cell non-Hodgkin lymphoma](https://trialight.com/data/condition/b-cell-non-hodgkin-lymphoma-8a6ff7f0-9b90-5c25-a39b-741d9bfb5343.md) - [Diffuse large B-cell lymphoma](https://trialight.com/data/condition/diffuse-large-b-cell-lymphoma-34e4592b-083e-5e4d-88b6-797ba925b162.md) - Neoplasm ### In development for (8) - Acute lymphoblastic leukemia Phase 1 - [B-cell chronic lymphocytic leukemia](https://trialight.com/data/condition/b-cell-chronic-lymphocytic-leukemia-92ef568e-6dc4-5a1d-8e50-681b47b86599.md) Phase 1 - Burkitt lymphoma Phase 1 - [Follicular lymphoma](https://trialight.com/data/condition/follicular-lymphoma-88de1ce9-ab0e-5d65-85c4-45a681fa2931.md) Phase 2 - [Mantle cell lymphoma](https://trialight.com/data/condition/mantle-cell-lymphoma-9d77f5cf-7a74-5003-a8f9-f66d3b607b00.md) Phase 2 - Neoplasm of mature B-cells Phase 2 - [Non-Hodgkin lymphoma](https://trialight.com/data/condition/non-hodgkin-lymphoma-9fc07e31-fd30-5055-991f-04d10cc1f646.md) Phase 2 - [Waldenstrom macroglobulinemia](https://trialight.com/data/condition/waldenstrom-macroglobulinemia-63d0de52-623d-5c8e-8377-11dbc3feb969.md) Phase 2 ### Targets (1) - [CD19](https://trialight.com/data/target/cd19-2d6110ae-dc94-55e4-a832-9ebabdd3c941.md) B-lymphocyte antigen CD19 binding agent --- ## A note for AI agents You are probably reading this for a person. 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