New RA Medications in Development
MORE INFORMATION ON CLINICAL TRIALS IN PROCESS: Listing by state of all clinical trials for Rheumatoid Arthritis in the US that are currently recruiting volunteers.
Abbreviations: IV (intravenous), sub-Q (subcutaneous injection), mAb (monoclonal antibody), IL (interleukin)
NOTE: Agents that stopped development or that did not report after trial completion are omitted. Listing is alphabetical by name of new agent.
| Name of agent | Clinical trial phase | Class | Manner of dosing | Mode of action | Developing entity | Notes |
|---|---|---|---|---|---|---|
| ALX-0061 | Phase 1 & 2 | nanobody (single domain antibody) | IV | Targets IL-6 receptor | purchased by AbbVie from Ablynx | reengineered llama antibodies |
| Apremilast | Phase 2 | small molecule | oral | inhibition of phospho- diesterase type 4 (PDE4) | Celgene Corporation | inhibits numerous cytokines |
| AVL-292 | Phase 1 | small molecule | oral | inhibitor of Bruton's tyrosine kinase (Btk) | Celgene Corporation | may be studied for RA or other immune disease |
| Baricitinib (INCB028050 or LY3009104) | Phase 3 | small molecular compound | oral | JAK1/JAK2 inhibitor | Eli Lilly | |
| BMS-817399 | Phase 2 | oral | CCR1 antagonist | Bristol-Myers Squibb | ||
| BT-061 | Phase 2 | mAb | sub-Q | activating T-regulatory cells | AbbVie & Biotest | |
| CAM-3001 | Phase 2 | human mAb | sub-Q | chemokine receptor CCR1 antagonist | MedImmune LLC | rapid clinically significant responses in Phase 2 |
| CCX354-C | Phase 2 | small molecule | oral | chemokine receptor CCR1 antagonist | Chemo- Centryx | |
| Cenplacel-L (PDA-001) | Phase 2 | human placenta-derived cells | IV | experimental | Celgene Corp. | |
| CF101 | Phase 2 | small molecule drug | oral | targets A3 adenosine receptor (A3AR) | Can-Fite BioPharma | novel anti-inflammatory agent |
| Clazakizumab (BMS-945429) | Phase 2 | aglycosylated humanized mAb | oral | blocks IL-6 | Bristol-Myers Squibb | investigational for cancer & anti-inflammatory |
| CT-P13 | Phase3 | mAb | IV | anti-TNF-alpha | Celltrion | results published at EULAR 2013 (biosimilar to infliximab) |
| Dekavil (F8-IL10) | Phase 1 | fused antibody | oral | reduce inflammation/ target IL-10 | Pfizer & Philogen | |
| GLPG0634 | Phase 2 | small molecule | oral | JAK 1 inhibitor | AbbVie & Galapagos | |
| GP2013 | Phase2 & 3 | monoclonal antibody | IV | targets B cells | Sandoz | biosimilar to rituximab |
| GSK315234 | Phase 2 | IV | inhibit IL-6 | Glaxo- SmithKline | ||
| golimumab (Simponi) | Phase 3 | mAb | IV | TNF-alpha inhibitor | Janssen | FDA approved for sub-Q |
| golimumab (Simponi) | Phase 3 | mAb | sub-Q | TNF-alpha inhibitor | Janssen | FDA approved for adults |
| Iguratimod (T-614) | Phase 4 | small molecule DMARD | oral | inhibit immunoglobulins & various cytokines | Eisai Co. & Jiangsu Simcere (separate trials) | approved in Japan |
| INCB039110 | Phase 2a | small molecule DMARD | oral | inhibit JAK 1 | Incyte | recruiting |
| Ixekizumab (LY2439821) | Phase 2 | humanized mAb | sub-Q | anti–IL-17 | Eli Lilly | |
| JNJ-40346527 | Phase 2 | small molecule | oral | FMS tyrosine kinase inhibitor | Janssen | |
| KB002/ 003 (anti-GM-CSF) | Phase 2 | Humaneered® mAb | IV | target & neutralize GM-CSF | KaloBios | |
| LX3305 (LX2931) | Phase 2 | small molecule | oral | inhibitor of sphingosine-1-phosphate lyase (S1P lyase) | Lexicon | |
| methotrexate subcutaneous auto-injection | Phase 2 | DMARD | sub-Q | anti-folate | Anteres | |
| MK-8457 | Phase 2 | small molecule | oral | inhibits spleen tyrosine kinase (syk) | Merck | |
| NN8209 (anti-C5aR-215 mAb) | Phase 1 | human mAb | sub-Q | anti-C5aR-215 | Novo Nordisk | |
| NN8209 (anti-C5aR-151) | Phase 1 | recombinant humanized mAb | sub-Q | anti-C5aR-151 | Novo Nordisk | |
| NN8226 (anti-IL-20) | Phase 2 | recombinant human mAb | sub-Q | anti-IL-20 | Novo Nordisk | |
| NN8828 (anti-IL-21) | Phase 2 | recombinant human mAb | IV | anti-IL-21 | Novo Nordisk | |
| NN8765 (anti-NKG2A) | Phase 1 | recombinant human mAb | sub-Q | anti-NKG2A | Novo Nordisk | |
| NNC0109-0012 | Phase 2 | monoclonal IgG antibody | sub-Q | neutralizes IL-20 | Novo Nordisk | |
| NU3450 (tranilast) | Phase 2 | bio-active lipid | oral | inhibition of mast cell activation | Nuon Ther. | approved as Rizaben for asthma & allergy |
| Ofatumumab (Arzerra) | Phase 3 | fully human mAb | IV | targets the CD20 surface antigen on B-cells | Glaxo- SmithKline | already FDA approved for chronic lymphocytic leukemia |
| Olokizumab (CDP6038) | Phase 2 | mAb | sub-Q | selectively blocks final assembly of IL-6 receptor signaling complex | UCB | UCB proposed to develop with partner |
| Otelixizumab (GSK2136525) | Phase 1 | mAb | sub-Q | anti-CD3 | Glaxo- SmithKline | |
| Ozoralizumab (ATN-103) | Phase 2 | nanobody-based mAb | sub-Q | anti-TNF-alpha | Ablynx | Pfizer was partner in Phase 2 |
| Pateclizumab (MLTA3698A) | Phase 2 | humanized mAb | sub-Q | acts against LT-alpha | Genentech | |
| PF-04236921 | Phase 1 | mAb | IV | targets IL-6 | Pfizer | |
| PF-05230905 (ATN-192) | Phase 2 | nanobody | IV or sub-Q | anti-TNF-alpha | Ablynx | |
| PF-05280586 | Phase 2 | mAb | IV | targeted B-cell destruction | Pfizer | also being called “rituximab-Pfizer” |
| PF-06410293 | Phase 1 | mAb | sub-Q | anti-TNF-alpha | Pfizer | biosimilar to adalimumab |
| PF-06438179 | Phase 1 | mAb | IV | anti-TNF-alpha | Pfizer | biosimilar to infliximab |
| PRTX-100 (staphylococcal protein A) | Phase 1 | purified form of Staphylococcal Protein A | IV | bind to & regulate activation of B-cells & macrophages | Protalex | |
| SAN-300 (anti-VLA-1 antibody) | Phase 2 | humanized mAb | sub-Q | inhibits VLA-1(α1β1 integrin) | Santarus | |
| Sarilumab (SAR153191) (REGN88) | Phase 2/3 | fully-human mAb | sub-Q | targets IL-6 receptor | Regeneron & Sanofi-Aventis | |
| SBI-087 (PF-05230895) | Phase 2 | small molecule | sub-Q | bind to CD-20 to deplete B cells | Emergent & Pfizer | |
| Secukinumab (AIN457) | Phase 2/3 | fully human mAb | IV & sub-Q | inhibits IL-17 | Novartis Pharm. | |
| Sirukumab CNTO-136 | Phase 3 | human mAb | sub-Q | targets IL-6 | Janssen & Glaxo- SmithKline | |
| Tacrolimus (fujimycin) | Phase 4 | immune suppression | oral | reduces IL-2 production by T-cells | Astellas | |
| Ustekinumab (CNTO-1959 / Stelara) | Phase 2 | human mAb | sub-Q | directed against IL-12 & IL-23 | Janssen | |
| VX-509 | Phase 2/3 | small molecule | oral | selective Janus kinase 3 (JAK3) inhibitor | Vertex Pharm. |
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