> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/elranatamab-43094116-a114-45cf-88c8-60ef9865def2 > Record changed: 2026-10-13 # Elranatamab Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297809) Drug type Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297809) First approval year 2023 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297809) ## Development status **First approval year** 2023 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297809) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297809) ## Names and chemistry **Drug type** Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297809) **Drug name** Elranatamab Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297809) ### Brand names (2) - elrexfio - Elrexfio ### Other names (32) - anti cd3 anti bcma bispecific monoclonal antibody pf 06863135 - ANTI-CD3/ANTI-BCMA BISPECIFIC MONOCLONAL ANTIBODY PF-06863135 - b cell maturation antigen bcma cluster of differentiation 3 cd3 bispecific monoclonal antibody mab anti bcma anti cd3 bispecific mab - B-CELL MATURATION ANTIGEN (BCMA) CLUSTER OF DIFFERENTIATION 3 (CD3) BISPECIFIC MONOCLONAL ANTIBODY (MAB) ANTI-BCMA/ANTI-CD3 BISPECIFIC MAB - elranatamab - Elranatamab - Elranatamab (Elra) - Elranatamab (PF-06863135) - elranatamab \[INN\] - Elranatamab \[MI\] - ELRANATAMAB \[USAN\] - Elranatamab \[WHO-DD\] - elranatamab bcmm - Elranatamab bcmm \[WHO-DD\] - elranatamab bcmm who dd - Elranatamab injection - elranatamab inn - elranatamab mi - elranatamab usan - elranatamab who dd - Elranatamab-bcmm - Immunoglobulin G2 \[224-arginine,265-alanine,330-serine,331-serine\], anti-(human CD3 antigen ε-chain) (human-Mus musculus monoclonal PF-06863059 γ2-chain), disulfide with human-Mus musculus monoclonal PF-06863059 κ-chain, (223→217′)(227→221′)(230→224′)-tris(disulfide) with immunoglobulin G2 \[218-glutamic acid,259-alanine,324-serine,325-serine\] anti-(human B-cell maturation antigen) (human monoclonal PF-06863058 γ2-chain) disulfide with human monoclonal PF-06863058 κ-chain - immunoglobulin g2 224 arginine 265 alanine 330 serine 331 serine anti human cd3 antigen ε chain human mus musculus monoclonal pf 06863059 γ2 chain disulfide with human mus musculus monoclonal pf 06863059 κ chain 223 217 227 221 230 224 tris disulfide with immunoglobulin g2 218 glutamic acid 259 alanine 324 serine 325 serine anti human b cell maturation antigen human monoclonal pf 06863058 γ2 chain disulfide with human monoclonal pf 06863058 κ chain - immunoglobulin g2 kappa anti homo sapiens t cell surface glycoprotein cd3 epsilon chain cd3e t cell surface antigen t3 leu 4 epsilon chain human mus musculus monoclonal disulfide with immunoglobulin g2 kappa anti homo sapiens tumor necrosis factor receptor superfamily member 17 tnr17 b cell maturation protein cd269 antigen human mus musculus monoclonal disulfide with immunoglobulin g2 kappa γ2 heavy chain anticd3e 1 447 homo sapiens vh ighv3 48 03 84 ighd ighj4 01 86 8 10 12 1 121 homo sapiens ighg2 01 hinge c5 r 224 e7 r 226 p10 r 229 ch2 d35 a 265 a100 s 330 p101 s 331 ch3 k69 r 409 122 447 135 219 disulfide with κ light chain anti cd3e 1 219 v kappa homo sapiens igkv4 1 01 90 igkj2 02 91 mus musculus igkv8 21 01 84 igkj4 01 12 3 8 1 112 homo sapiens igkc 01 113 219 223 217 227 221 230 224 trisdisulfide with γ2 heavy chain anti tnr17 1 441 homo sapiens vh ighv3 23 01 94 ighd ighj1 01 8 8 8 1 115 homo sapiens ighg2 01 hinge c5 e 218 p10 e 223 ch2 d35 a 259 a100 s 324 p101 s 325 ch3 l28 e 362 116 441 129 215 disulfide with κ light chain anti tnr17 1 215 homo sapiens v kappa homo sapiens igkv3 20 01 95 igkj1 01 7 3 9 1 108 homo sapiens igkc 01 109 215 - Immunoglobulin G2-kappa, anti-(Homo sapiens T-cell surface glycoprotein CD3 epsilon chain CD3E (T-cell surface antigen T3/Leu-4 epsilon chain)), human-Mus musculus monoclonal disulfide with immunoglobulin G2-kappa, anti-(Homo sapiens - Tumor necrosis factor receptor superfamily member 17 TNR17 (B-cell maturation protein; CD269\_antigen)), human-Mus musculus monoclonal disulfide with immunoglobulin G2-kappa. γ2 heavy chain antiCD3E (1-447) \[Homo sapiens VH (IGHV3-48\*03 (84%) –(IGHD)-IGHJ4\*01 (86%)) \[8.10.12\] (1-121) -Homo sapiens IGHG2\*01 {hinge\[C5>R(224),E7>R(226),P10>R(229)\], CH2\[D35>A(265), A100>S(330),P101>S(331)\], CH3\[K69>R(409)\]} (122-447)\] (135-219')-disulfide with κ light chain anti-CD3E (1'-219') \[V-KAPPA (Homo sapiens IGKV4-1\*01 (90%)-IGKJ2\*02 (91%)/Mus musculus IGKV8-21\*01 (84%)-IGKJ4\*01) \[12.3.8\] (1'-112') -Homo sapiens IGKC\*01 (113'-219')\]; (223-217'':227-221'':230-224'')-trisdisulfide with γ2 heavy chain anti-TNR17 (1''-441'') \[Homo sapiens VH (IGHV3-23\*01 (94%) –(IGHD)-IGHJ1\*01) \[8.8.8\] (1''-115'') -Homo sapiens IGHG2\*01 {hinge\[C5>E(218''),P10>E(223'')\], CH2\[D35>A(259''),A100>S(324''),P101>S(325'')\], CH3\[L28>E(362'')\]} (116''-441'') (129''-215''')-disulfide with κ light chain anti-TNR17 (1'''-215''') \[Homo sapiens V-KAPPA (Homo sapiens IGKV3-20\*01 (95%) –IGKJ1\*01)\[7.3.9\] (1'''-108''') -Homo sapiens IGKC\*01 (109'''-215''') And 7 more, listed on the interactive page. ## Identifiers **ATC classification codes** - L01FX32 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297809) **CAS registry numbers** - 2408850-14-4 **ChEMBL ID** CHEMBL4297809 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297809) **FDA ingredient codes (UNII)** - L0HR9A577V ### RxNorm IDs (RxCUI) (2) - 2644880 - 2644881 ## Regulatory information ### United States **Applicant** PFIZER INC **Approval date** 14 Aug 2023 **Application number** BLA761345 ### European Union **Status** Authorised **Status date** 7 Dec 2023 **Authorisation date** 7 Dec 2023 **Approved indications** Elrexfio is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. **Product number** EMEA/H/C/005908 **Authorisation holder** Pfizer Europe MA EEIG **Priority medicines scheme** Yes **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 - Multiple Myeloma European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/elrexfio) ### Other regulatory facts **Patents** 0 **Designations** 7 **Earliest recorded loss of exclusivity** 14 Aug 2030 **First in class** No **Fast track** Yes **Breakthrough designation** Yes **Orphan designation** No **Priority review** Yes **Orphan exclusivity** No **Accelerated approval** Yes **Availability** Prescription only **Boxed warning** Yes ## Pharmacology ### Drug classification **Pharmacology name** elranatamab **Type** Antibody **Drug name stem** \-mab **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Parenteral ### Mechanisms of action (4) - **Mechanism** T cell surface glycoprotein CD3 binding agent **Action type** BINDING\_AGENT **Target** T cell surface glycoprotein CD3 **Protein identifier** P04234 - **Mechanism** T cell surface glycoprotein CD3 binding agent **Action type** BINDING\_AGENT **Target** T cell surface glycoprotein CD3 **Protein identifier** P07766 - **Mechanism** T cell surface glycoprotein CD3 binding agent **Action type** BINDING\_AGENT **Target** T cell surface glycoprotein CD3 **Protein identifier** P09693 - **Mechanism** Tumor necrosis factor receptor superfamily member 17 binding agent **Action type** BINDING\_AGENT **Target** Tumor necrosis factor receptor superfamily member 17 **Protein identifier** Q02223 ### Open Targets mechanisms (2) - **Mechanism** T cell surface glycoprotein CD3 binding agent **Action type** BINDING AGENT **Target** T cell surface glycoprotein CD3 - **Mechanism** Tumor necrosis factor receptor superfamily member 17 binding agent **Action type** BINDING AGENT **Target** Tumor necrosis factor receptor superfamily member 17 ### Investigated indications (3) - **Condition** Neoplasms **Highest recorded phase** 4 **Condition identifier** EFO:0000616 **Subject identifier** D009369 - **Condition** Multiple Myeloma **Highest recorded phase** 4 **Condition identifier** EFO:0001378 **Subject identifier** D009101 - **Condition** Smoldering Multiple Myeloma **Highest recorded phase** 2 **Condition identifier** EFO:0003073 **Subject identifier** D000075122 ### Open Targets indications (12) - **Condition identifier** EFO\_0000616 - **Condition identifier** EFO\_0001378 - **Condition identifier** EFO\_0003073 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0000430 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005070 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005235 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0009693 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0015667 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0018881 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0018908 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0019438 - **Condition identifier** MONDO\_0019438 **Highest recorded phase** 1 ### Warnings - **Warning** Black Box Warning ### Open Targets warnings - **Warning** Black Box Warning **Country** United States ### Reported adverse events - **Event** cytokine release syndrome **Reports** 3 **Reporting signal score** 15.3875 ### Trial references (19) - NCT03269136 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03269136) - NCT04649359 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04649359) - NCT04798586 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04798586) - NCT05014412 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05014412) - NCT05020236 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05020236) - NCT05090566 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090566) - NCT05228470 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228470) - NCT05317416 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05317416) - NCT05623020 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05623020) - NCT05675449 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05675449) - NCT05927571 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05927571) - NCT06015542 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06015542) - NCT06057402 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06057402) - NCT06138275 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06138275) - NCT06152575 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06152575) - NCT06207799 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06207799) - NCT06215118 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215118) - NCT06282978 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06282978) - NCT06183489 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06183489) ## Dosing **Dose** 76mg **Route** Subcutaneous **How often** Weekly through week 24, then every 2 weeks from week 25 to 48, then every 4 weeks from week 49 onward ### Conditions of use (2) - Administer pre-treatment medications prior to each dose in the ELREXFIO step-up dosing schedule - Hospitalize for 48 hours after the first step-up dose, and 24 hours after the second ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ### Sequences (7) - **Component** Glycosylation sites (N) **Sequence** Asn-291'''' $ Asn-297 - **Component** Heavy chain: anti-CD3E **Type** Protein **Sequence** EVQLVESGGGLVQPGGSLRLSCAASGFTFSDYYMTWVRQAPGKGLEWVAFIRNRARGYTSDHNPSVKGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCARDRPSYYVLDYWGQGTTVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSNFGTQTYTCNVDHKPSNTKVDKTVERKCRVRCPRCPAPPVAGPSVFLFPPKPKDTLMISRTPEVTCVVVAVSHEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTFRVVSVLTVVHQDWLNGKEYKCKVSNKGLPSSIEKTISKTKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPMLDSDGSFFLYSRLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK - **Component** Heavy chain: anti-TNR17 **Type** Protein **Sequence** EVQLLESGGGLVQPGGSLRLSCAASGFTFSSYPMSWVRQAPGKGLEWVSAIGGSGGSLPYADIVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARYWPMDIWGQGTLVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSNFGTQTYTCNVDHKPSNTKVDKTVERKCEVECPECPAPPVAGPSVFLFPPKPKDTLMISRTPEVTCVVVAVSHEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTFRVVSVLTVVHQDWLNGKEYKCKVSNKGLPSSIEKTISKTKGQPREPQVYTLPPSREEMTKNQVSLTCEVKGFYPSDIAVEWESNGQPENNYKTTPPMLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK - **Component** Glycosylation sites (N) **Sequence** Asn-291'' $ Asn-297 - **Component** Disulfide bridges **Sequence** 22''-96'' $ 22-98 $ 23'''-89''' $ 23'-94' $ 135'''-195''' $ 139'-199' $ 142''-198'' $ 148-204 $ 215'''-129'' $ 219'-135 $ 217''-223 $ 221''- 227 $ 224''-230 $ 255''-315'' $ 261-321 $ 361''-419'' $ 367-425 - **Component** Light chain: anti-TNR17 **Type** Protein **Sequence** EIVLTQSPGTLSLSPGERATLSCRASQSVSSSYLAWYQQKPGQAPRLLMYDASIRATGIPDRFSGSGSGTDFTLTISRLEPEDFAVYYCQQYQSWPLTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC - **Component** Light chain: anti-CD3E **Type** Protein **Sequence** DIVMTQSPDSLAVSLGERATINCKSSQSLFNVRSRKNYLAWYQQKPGQPPKLLISWASTRESGVPDRFSGSGSGTDFTLTISSLQAEDVAVYYCKQSYDLFTFGSGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC ## National Drug Codes - 0069-2522 - 0069-4494 - 63539-252 ## Related records ### Trials (50) - A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multiple Myeloma - A Phase 1 Study of Vaccination With Dendritic Cell (DC)/Multiple Myeloma (MM) Fusions in Combination With Elranatamab in Relapsed or Refractory Multiple Myeloma - A Phase 2 Study of Radiotherapy-induced Immune Priming to Enhance Elranatamab (Elra) in Relapsed Refractory Multiple Myeloma (RRMM) With Extramedullary Disease (EMD) and Paramedullary Disease (PMD) "PRIME-EMD-PMD" - A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM) - A Study of Elranatamab (PF-06863135) in Chinese Participants With Refractory Multiple Myeloma. - A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma - A Study of Elranatamab for Inhibitor Eradication in Patients With Hemophilia A - A Study of Elranatamab Outpatient Administration in Patients With Relapsed/Refractory Multiple Myeloma - A Study to Compare the Effects of Elranatamab (PF 06863135) Versus Standard of Care (SOC) in Patients With Multiple Myeloma (MM) in Germany and US - A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With Elranatamab in Participants With Relapsed and/or Refractory Multiple Myeloma - [A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma](https://trialight.com/data/trial/a-study-to-evaluate-the-safety-effectiveness-and-tolerable-bf2618cc-f052-43c0-a005-bd672213d933.md) - A Study to Learn About the Effectiveness of the Medicine Called Elranatamab in People With Relapsed Refractory Multiple Myeloma - A Study to Learn About the Effectiveness of the Medicine Called Elranatamab in People With Relapsed Refractory Multiple Myeloma as Compared With Standard of Care Therapies - A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects - A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135) and Iberdomide in Patients With Relapsed or Refractory Multiple Myeloma (MagnetisMM-30) - [A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant](https://trialight.com/data/trial/a-study-to-learn-about-the-effects-of-the-combination-of-58c88ad0-cdc4-4b64-9c37-396ca8bd919e.md) - A Study to Learn About the Medicine (Called Elranatamab) in People With Relapsed Refractory Multiple Myeloma - A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment - A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments - ASPIRE: A Registry Study Of Chinese Patients With TCE-RRMM Treated By Elranatamab ### Approved for (2) - Neoplasm - [Plasma cell myeloma](https://trialight.com/data/condition/plasma-cell-myeloma-37186689-2591-5775-9042-2f2bf046a2b5.md) ### In development for (1) - Smoldering plasma cell myeloma Phase 2 ### Other linked conditions (1) - AL amyloidosis ### Targets (4) - [CD3D](https://trialight.com/data/target/cd3d-6bee5ce0-96ac-5607-815b-7dbf809d2a64.md) T cell surface glycoprotein CD3 binding agent - [CD3E](https://trialight.com/data/target/cd3e-b4b887fd-970b-55c2-bf21-d8b729fecbe7.md) T cell surface glycoprotein CD3 binding agent - [CD3G](https://trialight.com/data/target/cd3g-45960ced-28d6-5e39-be86-e6477c0df8f8.md) T cell surface glycoprotein CD3 binding agent - [TNFRSF17](https://trialight.com/data/target/tnfrsf17-07332eae-3a90-5bb8-8ec8-61ca7185c0e9.md) Tumor necrosis factor receptor superfamily member 17 binding agent --- ## A note for AI agents You are probably reading this for a person. 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