| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (from mouse) |
| Target | Nerve growth factor (NGF) |
| Clinical data | |
| Other names | RN624 |
| ATC code | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
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| UNII | |
| Chemical and physical data | |
| Formula | C6464H9942N1706O2026S46 |
| Molar mass | 145445.32 g·mol−1 |
  (what is this?) (verify) | |
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]
- ^ Oo WM, Hunter DJ (November 2021). "Nerve Growth Factor (NGF) Inhibitors and Related Agents for Chronic Musculoskeletal Pain: A Comprehensive Review". BioDrugs. 35 (6): 611–641. doi:10.1007/s40259-021-00504-8. PMID 34807432. S2CID 244509341.
- ^ Shelton DL, Zeller J, Ho WH, Pons J, Rosenthal A (July 2005). "Nerve growth factor mediates hyperalgesia and cachexia in auto-immune arthritis". Pain. 116 (1–2): 8–16. doi:10.1016/j.pain.2005.03.039. PMID 15927377. S2CID 36145654.
- ^ Clinical trial number NCT00733902 for "Tanezumab in Osteoarthritis of the Knee" at ClinicalTrials.gov
- ^ Clinical trial number NCT00744471 for "Tanezumab in Osteoarthritis Of The Hip" at ClinicalTrials.gov
- ^ "Trials Halted as Pfizer's Tanezumab Shown to Worsen Osteoarthritis". Genetic Engineering & Biotechnology News. 24 June 2010. Archived from the original on 23 January 2013.
- ^ "Phase II trials involving Tanezumab". ClinicalTrials.gov. U.S. National Library of Medicine.
- ^ "Tanezumab Arthritis Advisory Committee Briefing Document" (PDF). US Food and Drug Administration. 8 February 2012. Archived from the original (PDF) on 19 January 2017.
- ^ Verburg K. "Monoclonal Antibodies Targeted Against Nerve Growth Factor For the Treatment of Chronic Pain" (PDF). Medicines Development Group, Pfizer Inc. Archived from the original (PDF) on 9 May 2017.
- ^ Brown MT, Murphy FT, Radin DM, Davignon I, Smith MD, West CR (July 2013). "Tanezumab reduces osteoarthritic hip pain: results of a randomized, double-blind, placebo-controlled phase III trial". Arthritis and Rheumatism. 65 (7): 1795–1803. doi:10.1002/art.37950. PMID 23553790.
- ^ "Pfizer and Lilly Announce Top-line Results From Phase 3 Study of Tanezumab in Chronic Low Back Pain". Seeking Alpha. PR Newswire. February 19, 2019.