ACTEMRA (tocilizumab)
ACTEMRA is indicated for the treatment of Rheumatoid Arthritis; Giant Cell Arteritis; Systemic Sclerosis-Associated Interstitial Lung Disease; Polyarticular Juvenile Idiopathic Arthritis; Systemic Juvenile Idiopathic Arthritis; Cytokine Release Syndrome; Coronavirus Disease 2019 (COVID-19).
How ACTEMRA Works
Tocilizumab binds to both soluble and membrane-bound interleukin-6 (IL-6) receptors to inhibit IL-6-mediated signaling. IL-6 is a pro-inflammatory cytokine produced by various cell types that is involved in physiological processes such as T-cell activation, immunoglobulin secretion, and the initiation of hepatic acute phase protein synthesis. By blocking these receptors, the drug disrupts the inflammatory signaling pathways that contribute to joint damage and systemic inflammation. In conditions like rheumatoid arthritis, this action reduces the local production of IL-6 by synovial and endothelial cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2010-01-08
- Patent Cliff
- 2026
- Revenue
- $681M (Q4-2025)
- Routes
- INTRAVENOUS, SUBCUTANEOUS, INJECTION
- Dosage Forms
- INJECTABLE
ACTEMRA Approval History
What ACTEMRA Treats
7 indicationsACTEMRA is approved for 7 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Rheumatoid Arthritis
- Giant Cell Arteritis
- Systemic Sclerosis-Associated Interstitial Lung Disease
- Polyarticular Juvenile Idiopathic Arthritis
- Systemic Juvenile Idiopathic Arthritis
- Cytokine Release Syndrome
- Coronavirus Disease 2019 (COVID-19)
ACTEMRA Boxed Warning
RISK OF SERIOUS INFECTIONS Patients treated with ACTEMRA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt ACTEMRA until the infection is controlled. Reported infections include: Active tuberculosis, which may pres...
WARNING: RISK OF SERIOUS INFECTIONS Patients treated with ACTEMRA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt ACTEMRA until the infection is controlled. Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients, except those with COVID-19, should be tested for latent tuberculosis before ACTEMRA use and during therapy. Treatment for latent infection should be initiated prior to ACTEMRA use. Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. Bacterial, viral and other infections due to opportunistic pathogens. The risks and benefits of treatment with ACTEMRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ACTEMRA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy [see Warnings and Precautions (5.1) ] . WARNING: RISK OF SERIOUS INFECTIONS See full prescribing information for complete boxed warning. Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial, invasive fungal, viral, and other opportunistic infections have occurred in patients receiving ACTEMRA. ( 5.1 ) If a serious infection develops, interrupt ACTEMRA until the infection is controlled. ( 5.1 ) Perform test for latent TB (except patients with COVID-19); if positive, start treatment for TB prior to starting ACTEMRA.
ACTEMRA Target & Pathway
ProTarget
A cytokine involved in inflammation and immune regulation. Elevated IL-6 drives inflammation in rheumatoid arthritis and is linked to cytokine release syndrome. Blocking IL-6 or its receptor reduces inflammatory responses in autoimmune conditions.
ACTEMRA Biosimilars
4 FDA-approved1 can be substituted at the pharmacy without calling the prescriber. The other 3 require prescriber approval to switch.
What are biosimilars? Lower-cost alternatives to ACTEMRA with no clinically meaningful differences.
Auto-substitute OK = FDA "interchangeable" designation — pharmacist can switch without calling the doctor.
ACTEMRA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ACTEMRA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ACTEMRA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ACTEMRA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
245 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07570173 | 1045-005 MK-1045-005, 2025-522267-15-00 | Ph 2, Ph 3 | recruiting | A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005) |
| NCT03337698 Morpheus Lung results posted | BO39610 2017-001267-21 | Ph 1, Ph 2 | terminated | A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) |
| NCT07281027 COMBAT-NORSE | 2000041289 RD-2024C2-39648 | Ph 3 | not yet recruiting | COMparison Between Anakinra and Tocilizumab in NORSE - "COMBAT-NORSE" |
| NCT07263776 IRIS-2 | IRIS-2 | Ph 3 | recruiting | Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Anterior Circulation Large Vessel Occlusion Stroke -2 |
| NCT05835986 | BP44315 2022-502632-39-00 | Ph 1 | recruiting | A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus |
| NCT06934044 | YO43835 | Ph 1 | recruiting | A Study Evaluating the Pharmacokinetics, Safety, and Efficacy of Cevostamab in Chinese Participants With Relapsed or Refractory Multiple Myeloma |
| NCT03564340 | R4018-ONC-1721 2024-510783-23-00, 2019-003298-24 | Ph 1, Ph 2 | recruiting | Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers |
| NCT05846789 | CTO-IUSCCC-0817 | Ph 2 | recruiting | SOC Chemotherapy +/- Tocilizumab for Triple Negative and ER-low Breast Cancers |
| NCT05535244 CAMMA 2 | CO43476 2021-006816-10 | Ph 1, Ph 2 | active not recruiting | A Study Evaluating the Efficacy and Safety of Cevostamab in Prior B Cell Maturation Antigen (BCMA)-Exposed Participants With Relapsed/Refractory Multiple Myeloma |
| NCT07573332 | CA061-1031 | Ph 1 | not yet recruiting | A Safety and Tolerability Study of CC- 97540 (BMS-086353) in Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Patients |
| NCT05171647 SUNMO results posted | GO43643 | Ph 3 | active not recruiting | A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma |
| NCT07509645 IRIS-3 | IRIS-3 | Ph 3 | recruiting | Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Posterior Circulation Large Vessel Occlusion Stroke |
| NCT05869955 | CA061-1001 2023-503823-24 | Ph 1 | recruiting | A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1) |
| NCT05533775 iMATRIX GLO | CO43810 | Ph 1, Ph 2 | recruiting | A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma |
| NCT05583617 PLYCOM | CO43923 2021-005918-34, 2023-504484-16-00 | Ph 1, Ph 2 | recruiting | A Study Evaluating the Safety and Efficacy of Multiple Treatments in Participants With Multiple Myeloma |
| NCT06084936 GLOBRYTE | GO43878 | Ph 3 | recruiting | A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma |
| NCT06624085 | GO44900 | Ph 1 | recruiting | A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma |
| NCT05091424 | BO43243 | Ph 1 | recruiting | A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia |
| NCT05927571 | GO43979 2023-504657-13-00 | Ph 1 | recruiting | 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) |
| NCT07113743 | 10000186 000186-I | Ph 1, Ph 2 | enrolling by invitation | Part B- G1X-CGD (Lentiviral Vector Transduced CD34+ Cells) in Patients With X-Linked Chronic Granulomatous Disease |
| NCT03075696 | NP30179 2016-001185-28, 2023-505625-14-00 | Ph 1, Ph 2 | active not recruiting | A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma |
| NCT07115745 | IM060-0001 2024-517681-41, U1111-1308-9273 | Ph 1 | recruiting | A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases |
| NCT07493317 | STUDY-25-01000 | Ph 2 | recruiting | Neutralizing Interleukin (IL)-6 |
| NCT04524871 MORPHEUS-LIVER | GO42216 | Ph 1, Ph 2 | recruiting | A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver) |
| NCT05233397 | CONNECT1905 | Ph 2 | recruiting | ACTEMRA® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma |
| NCT05972135 | MM165 | Ph 2 | recruiting | Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma |
| NCT04381936 RECOVERY | NDPHRECOVERY 2020-001113-21, ISRCTN50189673 | Ph 3 | recruiting | Randomised Evaluation of COVID-19 Therapy |
| NCT05169515 | CO43805 | Ph 1 | recruiting | A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma |
| NCT06654882 SMART-JIA | Pro00115808 PLACER-2022C3-30331, EPM #8533 | Ph 3 | recruiting | Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis |
| NCT07108387 | DAIT AGA01 | Ph 2 | recruiting | Tocilizumab Discontinuation Versus Dose Reduction for Patients With Well-Controlled Giant Cell Arteritis |
| NCT06297096 NINTOC-TU | NIGRIR_004NINTOC-TU | Ph 3 | recruiting | Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease |
| NCT03644667 | DAIT RTB-004 ALL IN, U01AI136816 | Ph 2 | completed | Tocilizumab in Cardiac Transplantation |
| NCT04408638 | GO41944 2020-001021-31 | Ph 3 | active not recruiting | A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma |
| NCT03533283 | NP39488 | Ph 1, Ph 2 | active not recruiting | An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma |
| NCT05640271 | IRB22-0277 | Ph 2 | recruiting | Tocilizumab for Acute Chest Syndrome |
| NCT04871191 SATELITE | P200026 | Ph 3 | recruiting | Study of Salvage Therapy to Treat Patients With Granulomatosis With Polyangiitis |
| NCT04729959 | NCI-2021-00410 NCI-2021-00410, NRG-BN010 | Ph 2 | active not recruiting | Testing the Addition of the Immune Therapy Drugs, Tocilizumab and Atezolizumab, to Radiation Therapy for Recurrent Glioblastoma |
| NCT04479358 COVIDOSE-2 results posted | IRB20-1179 | Ph 2 | terminated | Low-dose Tocilizumab Versus Standard of Care in Hospitalized Patients With COVID-19 |
| NCT06033196 ALL IN LUNG | DAIT CTOT-45 | Ph 2 | recruiting | Tocilizumab in Lung Transplantation |
| NCT02840175 AJIBIOREM | P 150902 2016-000312-15 | Ph 3 | completed | Treatment Tapering in JIA With Inactive Disease |
| NCT04246086 | CO41942 2019-004291-20 | Ph 1, Ph 2 | active not recruiting | A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Participants With Follicular Lymphoma |
| NCT04910568 CAMMA 1 | GO42552 2021-000238-33 | Ph 1 | active not recruiting | A Study Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma |
| NCT03424005 Morpheus-panBC | CO40115 2017-002038-21, 2023-503629-20-00 | Ph 1, Ph 2 | recruiting | A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer |
| NCT03999749 results posted | 19-00008 | Ph 2 | active not recruiting | A Phase II Study of the Interleukin-6 Receptor Inhibitor Tocilizumab in Combination With Ipilimumab and Nivolumab in Patients With Unresectable Stage III or Stage IV Melanoma |
| NCT04940299 | 2020-1166 NCI-2021-04325, 2020-1166 | Ph 2 | active not recruiting | Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma |
| NCT05207670 MorningSun | ML43389 | Ph 2 | active not recruiting | A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab Monotherapy in Participants With Select B-Cell Malignancies |
| NCT07335562 Breakfree-SSc | CA061-1005 2025-524337-11, U1111-1330-3381 | Ph 3 | recruiting | A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis |
| NCT04077723 | BP41072 2019-000416-28, 2022-502616-37-00 | Ph 1, Ph 2 | active not recruiting | A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Englumafusp Alfa in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma |
| NCT03448042 | GO40311 | Ph 1 | active not recruiting | A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers |
| NCT05646836 | GO43980 2022-001204-18, 2023-505212-38-00 | Ph 1 | active not recruiting | A Study to Evaluate the Safety, Pharmacokinetics, and Activity of XmAb24306 in Combination With Cevostamab in Participants With Relapsed/Refractory Multiple Myeloma |
Showing 50 of 245 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ACTEMRA FDA Label Details
Indications & Usage
FDA Label (PDF)ACTEMRA is indicated for the treatment of Rheumatoid Arthritis; Giant Cell Arteritis; Systemic Sclerosis-Associated Interstitial Lung Disease; Polyarticular Juvenile Idiopathic Arthritis; Systemic Juvenile Idiopathic Arthritis; Cytokine Release Syndrome; Coronavirus Disease 2019 (COVID-19).
WARNING: RISK OF SERIOUS INFECTIONS Patients treated with ACTEMRA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ] . Most patients who developed these infections were taking concomitant i...
Pro Intelligence Preview
Deep insights for ACTEMRA
Revenue Insights
- • Q4-2025: $681M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2026
- • Generic/biosimilar risk
Trial Analysis
- • 249 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment