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Drug

Teclistamab

Approved medicine
ClassTumor necrosis factor receptor superfamily member 17 binding agentResearchOngoing clinical research

Also known as Tecvayli.

RxNorm2619426ChEMBLCHEMBL4594505ATCL01FX24UNII54534MX6Z9
48
Active clinical trials
4
Protein targets
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Teclistamab and Mezigdomide for Relapsed/Refractory Multiple Myeloma

Clinical trial2026-08-17Results expected Q3 2028 · ClinicalTrials.gov

A Phase II Study to Evaluate the Efficacy and Safety of Teclistamab in Combination With Daratumumab (Tec-Dara) in Newly Diagnosed Multiple Myeloma With Concurrent Light Chain Amyloidosis (MM+AL)

Clinical trial2026-08-03Results expected Q3 2028 · ClinicalTrials.gov

A Phase 3 Randomized Study Comparing JNJ-79635322 Versus Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma After 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Antibody and Lenalidomide

Clinical trial2026-07-31Results expected Q2 2029 · ClinicalTrials.gov

64407564MMY3009: A Phase 3 Randomized Study Comparing Talquetamab in Combination With Pomalidomide (Tal-P), Talquetamab in Combination With Teclistamab (Tal-Tec), and Investigator's Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pom

Clinical trial2026-07-30Status changed to Active, not recruiting · ClinicalTrials.gov

A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis

Clinical trial2026-07-20Status changed to Active, not recruiting · ClinicalTrials.gov

Phase 2 Study of Cytokine Release Syndrome Prophylaxis With Infliximab for Teclistamab/Talquetamab Therapy in Patients With Relapsed/Refractory Myeloma

Clinical trial2026-07-08Results expected Q4 2027 · ClinicalTrials.gov

A Phase 1b Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Subjects With Multiple Myeloma

Clinical trial2026-07-06Results expected Q2 2027 · ClinicalTrials.gov

A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of Different Sequences of Ciltacabtagene Autoleucel (Cilta-cel), Talquetamab SC in Combination With Daratumumab SC (Tal-D) and Teclistamab SC in Combination With Daratumumab SC (Tec-D) Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) in Participants With Standard-risk Newly Diagnosed Multiple Myeloma

Clinical trial2026-07-06Results expected Q3 2030 · ClinicalTrials.gov

A Phase 3 Randomized Study Comparing JNJ-79635322 and an Anti-BCMAxCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti CD38 Antibody

Clinical trial2026-07-06Results expected Q4 2028 · ClinicalTrials.gov

A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy

Clinical trial2026-07-06Results expected Q2 2031 · ClinicalTrials.gov

An Open Label, Multicenter, Phase IV Study of Teclistamab to Evaluate Its Safety in Indian Participants With Relapsed and Refractory Multiple Myeloma Who Have Previously Received at Least 3 Prior Lines of Therapy Including an Immunomodulatory Agent, a Proteasome Inhibitor and an Anti-CD38 Antibody and Have Demonstrated Disease Progression on the Last Therapy

Clinical trial2026-07-06Results expected Q4 2026 · ClinicalTrials.gov

Approval: Tecvayli (EMA)

Regulatory2022-08-23EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Teclistamab
Aliases & brands
Tecvayli
RxNorm CUI
2619426
ChEMBL ID
CHEMBL4594505
ATC codes
L01FX24
UNII
54534MX6Z9
Primary mechanism
Tumor necrosis factor receptor superfamily member 17 binding agent
Regulatory jurisdictions
ema

Pharmacology & targets

4 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Tumor necrosis factor receptor superfamily member 17
TNFRSF17 · Q02223
BINDING AGENTTumor necrosis factor receptor superfamily member 17 binding agent
T-cell surface glycoprotein CD3 epsilon chain
CD3E · P07766
BINDING AGENTT cell surface glycoprotein CD3 binding agent
T-cell surface glycoprotein CD3 gamma chain
CD3G · P09693
BINDING AGENTT cell surface glycoprotein CD3 binding agent
T-cell surface glycoprotein CD3 delta chain
CD3D · P04234
BINDING AGENTT cell surface glycoprotein CD3 binding agent

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2022-08-23
Latest approval
2022-08-23
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2022-08-23Approval
Approval: Tecvayli (EMA)
Indication: TECVAYLI 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… Show full indication

TECVAYLI 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.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

51 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
51
registered trials across all phases
LATEST COMPLETION 2026
48
Active studies
33
Recruiting
12
Late-stage (III+)
1
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 51
Phase 110Phase 1 / 24Phase 225Phase 39Phase 42Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

An Open Label, Multicenter, Phase IV Study of Teclistamab to Evaluate Its Safety in Indian Participants With Relapsed and Refractory Multiple Myeloma Who Have Previously Received at Least 3 Prior Lines of Therapy Including an Immunomodulatory Agent, a Proteasome Inhibitor and an Anti-CD38 Antibody and Have Demonstrated Disease Progression on the Last Therapy

RecruitingPH IVJohnson & Johnson Private Limitedn=752027

Outpatient-based Teclistamab Step-up Dosing in Patients With Relapsed/Refractory Multiple Myeloma: Process Development in Academic and Community Centres, and Evaluating Impact on Caregiver Burden

RecruitingPH IVUniversity Health Network, Toronton=152026

iFIT (UK-MRA Myeloma XVIII): Immunotherapy Approaches Adapted for Fitness in Newly Diagnosed Transplant Ineligible Patients With Myeloma

Not yet recruitingPH IIIKey trialUniversity of Leedsn=1,2262037

A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy

RecruitingPH IIIKey trialJanssen Research & Development, LLCn=1,5902033

Accelerate Improvement in Multiple Myeloma for Newly Diagnosed Transplant-Eligible Patients

Not yet recruitingPH IIIUniversity of Heidelberg Medical Centern=3992033

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1/2 Study of JNJ-64007957, a Humanized BCMA * CD3 Bispecific Antibody in Japanese Patients With Relapsed or Refractory Multiple Myeloma

CompletedPH I/IIJanssen Pharmaceutical K.K.n=402026
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.