Monoclonal antibody | |
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Type | Whole antibody |
Source | Humanized (from mouse) |
Target | Nerve growth factor (NGF) |
Clinical data | |
Other names | RN624 |
ATC code | |
Identifiers | |
CAS Number | |
DrugBank |
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ChemSpider |
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UNII | |
Chemical and physical data | |
Formula | C6464H9942N1706O2026S46 |
Molar mass | 145445.32 g·mol−1 |
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Tanezumab (INN, codenamed RN624) is a monoclonal antibody against nerve growth factor as a treatment for pain via a novel mechanisms different from conventional pain-killer drugs.[1] Tanezumab was discovered and developed by Rinat Neuroscience[2] and was acquired by Pfizer in 2006.
In 2009 there was a Phase III trial for knee pain due to osteoarthritis (OA).[3] Another Phase III trial for hip pain in OA[4] was halted in June 2010 when some patients needed hip replacement.[5]
Tanezumab is undergoing Phase II clinical trials for the treatment of various pain entities, including chronic low back pain, bone cancer pain, and interstitial cystitis.[6]
In March 2012, the Anti-NGF Testing - FDA Committee voted in favor of a continuation of the development of nerve-blocking medications, as long as certain safety precautions were observed.[7][8]
A Phase III trial published in 2013 found tanezumab was superior to placebo for painful hip osteoarthritis.[9]
At February 19, 2019 the co-development partners - Eli Lilly and Pfizer - announced that treatment with tanezumab 10 mg met the primary endpoint, demonstrating a statistically significant improvement in chronic low back pain at 16 weeks compared to placebo (however, 5 mg arm demonstrated a numerical improvement in pain, but did not reach statistical significance compared to placebo at the week 16 analysis).[10]
On 16 September 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the refusal of the marketing authorization for tanezumab (Raylumis), a medicine intended for the treatment of pain associated with osteoarthritis.[11]
On 25 March 2021, the FDA Joint Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 1 to 19 against the question : on whether the proposed risk evaluation and mitigation strategy (REMS) for tanezumab will ensure its benefits outweigh its risks. [12]
Monoclonals for bone, musculoskeletal, circulatory, and neurologic systems
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Bone |
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Musculoskeletal |
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Circulatory |
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Neurologic |
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Angiogenesis inhibitor |
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Growth factor |
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Angiopoietin |
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CNTF |
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EGF (ErbB) |
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FGF |
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HGF (c-Met) |
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IGF |
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LNGF (p75NTR) |
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PDGF |
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RET (GFL) |
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SCF (c-Kit) |
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TGFβ |
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Trk |
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VEGF |
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Others |
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