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Revision as of 18:40, 9 January 2012 editBeetstra (talk | contribs)Edit filter managers, Administrators172,031 edits Saving copy of the {{drugbox}} taken from revid 460516063 of page Tanezumab for the Chem/Drugbox validation project (updated: 'CAS_number').  Latest revision as of 02:39, 16 July 2024 edit Whywhenwhohow (talk | contribs)Autopatrolled, Extended confirmed users, Pending changes reviewers49,132 edits update refs 
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{{Short description|Chemical compound}}
{{ambox | text = This page contains a copy of the infobox ({{tl|drugbox}}) taken from revid of page ] with values updated to verified values.}}
{{Drugbox {{Drugbox
| Verifiedfields = changed | Verifiedfields = changed
| Watchedfields = changed
| verifiedrevid = 450329557 | verifiedrevid = 470477328
⚫ | image =

⚫ <!--Monoclonal antibody data-->
| type = mab | type = mab
⚫ | image =
| alt =

⚫ <!-- Monoclonal antibody data -->
| mab_type = mab | mab_type = mab
| source = zu/o | source = zu/o
| target = ] | target = ] (NGF)


<!--Clinical data--> <!-- Clinical data -->
| tradename = | tradename =
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X --> | pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_US = <!-- A / B / C / D / X -->
| pregnancy_category = | pregnancy_category =
⚫ | routes_of_administration =
⚫ | legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled-->
⚫ | ATC_prefix = N02
⚫ | ATC_suffix = BG12

⚫ | legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled -->
| legal_CA = <!-- Schedule I, II, III, IV, V, VI, VII, VIII --> | legal_CA = <!-- Schedule I, II, III, IV, V, VI, VII, VIII -->
| legal_UK = <!-- GSL, P, POM, CD, or Class A, B, C --> | legal_UK = <!-- GSL, P, POM, CD, or Class A, B, C -->
| legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V --> | legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V -->
| legal_status = | legal_status =
⚫ | routes_of_administration =


<!--Pharmacokinetic data--> <!-- Pharmacokinetic data -->
| bioavailability = | bioavailability =
| protein_bound = | protein_bound =
| metabolism = | metabolism =
| elimination_half-life = | elimination_half-life =
| excretion = | excretion =


<!--Identifiers--> <!-- Identifiers -->
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}} | ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| ChemSpiderID = NA | ChemSpiderID = none
| CAS_number_Ref = {{cascite|correct|??}} | CAS_number_Ref = {{cascite|changed|??}}
| CAS_number = <!-- blanked - oldvalue: 880266-57-9 --> | CAS_number = 880266-57-9
⚫ | ATC_prefix = none
⚫ | ATC_suffix =
| PubChem = | PubChem =
| DrugBank_Ref = {{drugbankcite|correct|drugbank}} | DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank = | DrugBank = DB12335
| UNII_Ref = {{fdacite|correct|FDA}} | UNII_Ref = {{fdacite|correct|FDA}}
| UNII = EQL0E9GCX1 | UNII = EQL0E9GCX1

⚫ <!--Chemical data-->
⚫ | C=6464 | H=9942 | N=1706 | O=2026 | S=46
| molecular_weight = 145.4 ]
| synonyms = RN624 | synonyms = RN624

⚫ <!-- Chemical data -->
⚫ | C=6464 | H=9942 | N=1706 | O=2026 | S=46
}} }}

'''Tanezumab''' (], codenamed '''RN624''') is a ] against ] as a treatment for pain via a novel mechanisms different from conventional pain-killer drugs.<ref>{{cite journal | vauthors = Oo WM, Hunter DJ | title = Nerve Growth Factor (NGF) Inhibitors and Related Agents for Chronic Musculoskeletal Pain: A Comprehensive Review | journal = BioDrugs | volume = 35 | issue = 6 | pages = 611–641 | date = November 2021 | pmid = 34807432 | doi = 10.1007/s40259-021-00504-8 | s2cid = 244509341 }}</ref> Tanezumab was discovered and developed by ]<ref>{{cite journal | vauthors = Shelton DL, Zeller J, Ho WH, Pons J, Rosenthal A | title = Nerve growth factor mediates hyperalgesia and cachexia in auto-immune arthritis | journal = Pain | volume = 116 | issue = 1–2 | pages = 8–16 | date = July 2005 | pmid = 15927377 | doi = 10.1016/j.pain.2005.03.039 | s2cid = 36145654 }}</ref> and was acquired by ] in 2006.

In 2009 there was a ] trial for knee pain due to ].<ref>{{ClinicalTrialsGov|NCT00733902|Tanezumab in Osteoarthritis of the Knee}}</ref>
Another Phase III trial for hip pain in OA<ref>{{ClinicalTrialsGov|NCT00744471|Tanezumab in Osteoarthritis Of The Hip}}</ref> was halted in June 2010 when some patients needed hip replacement.<ref>{{cite web | title = Trials Halted as Pfizer's Tanezumab Shown to Worsen Osteoarthritis | date = 24 June 2010 | work = Genetic Engineering & Biotechnology News | url = http://www.genengnews.com/gen-news-highlights/trials-halted-as-pfizer-s-tanezumab-shown-to-worsen-osteoarthritis/81243572/ | archive-url = https://web.archive.org/web/20130123043725/http://www.genengnews.com/gen-news-highlights/trials-halted-as-pfizer-s-tanezumab-shown-to-worsen-osteoarthritis/81243572/ | archive-date = 23 January 2013 }}</ref>

Tanezumab is undergoing ] clinical trials for the treatment of various pain entities, including chronic low back pain, ], and ].<ref>{{cite web |url=http://www.clinicaltrials.gov/ct2/results?term=Tanezumab&phase=1 |title=Phase II trials involving Tanezumab | work = ClinicalTrials.gov | publisher = U.S. National Library of Medicine }}</ref>

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.<ref>{{cite web | title = Tanezumab Arthritis Advisory Committee Briefing Document | date = 8 February 2012 | publisher = US Food and Drug Administration | url = https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM295205.pdf | archive-url = https://web.archive.org/web/20170119055305/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM295205.pdf | archive-date = 19 January 2017 }}</ref><ref>{{cite web | vauthors = Verburg K | title = Monoclonal Antibodies Targeted Against Nerve Growth Factor For the Treatment of Chronic Pain | work = Medicines Development Group, Pfizer Inc. | url = https://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/arthritisadvisorycommittee/ucm301305.pdf | archive-url = https://web.archive.org/web/20170509180502/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM301305.pdf | archive-date = 9 May 2017 }}</ref>

A Phase III trial published in 2013 found tanezumab was superior to placebo for painful hip osteoarthritis.<ref>{{cite journal | vauthors = Brown MT, Murphy FT, Radin DM, Davignon I, Smith MD, West CR | title = Tanezumab reduces osteoarthritic hip pain: results of a randomized, double-blind, placebo-controlled phase III trial | journal = Arthritis and Rheumatism | volume = 65 | issue = 7 | pages = 1795–1803 | date = July 2013 | pmid = 23553790 | doi = 10.1002/art.37950 | doi-access = free }}</ref>

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).<ref>{{cite web|url=https://seekingalpha.com/pr/17415547-pfizer-lilly-announce-top-line-results-phase-3-study-tanezumab-chronic-low-back-pain|title=Pfizer and Lilly Announce Top-line Results From Phase 3 Study of Tanezumab in Chronic Low Back Pain | date = February 19, 2019 | publisher = PR Newswire |website=Seeking Alpha}}</ref>

== Society and culture ==
=== Legal status ===
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.<ref>{{cite web | title=Raylumis: Pending EC decision | website=European Medicines Agency | date=17 September 2021 | url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/raylumis | access-date=17 September 2021}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref>

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. <ref>{{cite web | title= Transcript for the March 25, 2021 Joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee | website=US Food and Drug administration | date=25 March 2021 | url = https://www.fda.gov/media/150663/download | access-date=22 February 2022 }}</ref>

== See also ==
* ]

== References ==
{{Reflist}}

== External links ==
*

{{Analgesics}}
{{Monoclonals for bone, musculoskeletal, circulatory, and neurologic systems}}
{{Growth factor receptor modulators}}

]
]
]


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