Delving into the Latest Updates on Tanezumab with Synapse

Tanezumab is a monoclonal antibody that binds to and inhibits the actions of nerve growth factor (NGF). The Nerve Growth Factor Inhibitor (NGFI) class may offer an important breakthrough in the treatment of chronic pain and is under clinical investigation for the treatment of pain associated with osteoarthritis or other chronic pain conditions.
The primary objective of this study is to demonstrate superior efficacy of tanezumab 5 mg and 2.5 mg administered subcutaneously (SC) every 8 weeks versus placebo at Week 24 in subjects with osteoarthritis of the knee or hip. The 2.5 mg dose was shown to provide efficacy benefits with a favorable safety profile when administered intravenously in previous Phase 3 clinical trials. The 5 mg dose is expected to provide added efficacy benefit over the 2.5 mg dose based on data from previous studies.

Start Date02 Mar 2016

Sponsor / Collaborator

Pfizer Inc.

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100 Clinical Results associated with Tanezumab

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100 Translational Medicine associated with Tanezumab

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100 Patents (Medical) associated with Tanezumab

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147

Literatures (Medical) associated with Tanezumab

01 Sep 2025·CPT-Pharmacometrics & Systems Pharmacology

Incorporating Multiple Imputation Into Tanezumab Dose–Response Modeling of WOMAC Pain CFB Across Six Randomized Placebo‐Controlled Phase 3 Trials

Article

Author: Marshall, Scott ; Boucher, Martin ; Gaitonde, Puneet

ABSTRACT:

Multiple imputation is increasingly being used to deal with missing data in clinical trials. It is a simulation approach leading to multiple analyses of a pre‐defined number of datasets. For a pre‐defined statistical model, this is relatively straightforward, but for model development as typically conducted in Pharmacometrics, it is unclear how such an approach could be implemented. This case study describes how this was addressed at the time of a regulatory submission and considers alternative approaches which could be adopted in the future.

01 Aug 2024·VETERINARY JOURNAL

Re: Re: Laboratory safety evaluation of bedinvetmab, a canine anti-nerve growth factor monoclonal antibody, in dogs

Letter

Author: Reece, Douglas ; Cole, Phaedra ; Simon, Tony ; Werts, Adam

In their letter to the editor, Farrell et al., (2024) presented questions related to canine joint health after treatment with the anti-Nerve Growth Factor (NGF) monoclonal antibody (mAb) bedinvetmab, which was presented as a component of a non-clinical laboratory safety assessment published in Krautmann et al., (2021). Their questions appear to have stemmed from an anti-NGF mAb developed for the treatment of osteoarthritis in humans (tanezumab; FDA, 2021) which in 2021 failed to achieve marketing approval due to an unfavorable benefit: risk profile, primarily due to a syndrome called Rapidly Progressive Osteoarthritis (RPOA) which occurred more commonly in treatment groups when compared to controls. Farrell et. al. (2024) have posed questions on radiographic and histopathologic bone findings from studies included in Krautmann, et al., (2021) and communicated in the FDA's Freedom of Information summary for Librela (FDA, 2023). These findings have previously been determined to be incidental and not bedinvetmab-associated. To address the questions posed, it is important to briefly define RPOA and summarize the syndrome in humans, review why the bone/joint findings in bedinvetmab safety studies in dogs are not indicative of RPOA or an RPOA-like condition, provide an update on joint health after use of bedinvetmab since market approval (>3 years in some markets), and summarize why Zoetis, the manufacturer of Librela, has confidence in joint safety after use of bedinvetmab in dogs.

11 Dec 2023·The oncologist

A Randomized Placebo-Controlled Trial of the Anti-Nerve Growth Factor Antibody Tanezumab in Subjects With Cancer Pain Due to Bone Metastasis

Article

Author: Fallon, Marie ; Bao, Weihang ; Viktrup, Lars ; Brown, Mark T ; Agyemang, Alex ; Sopata, Maciej ; West, Christine R ; Dragon, Erika

Abstract:

Background:

This phase III, randomized, double-blind, placebo-controlled, parallel-group study assessed the efficacy and safety of tanezumab in subjects with cancer pain predominantly due to bone metastasis receiving background opioid therapy.

Methods:

Subjects were randomized (stratified by (1) tumor aggressiveness and (2) presence/absence of concomitant anticancer treatment) to placebo or tanezumab 20 mg. Treatment was administered by subcutaneous injection every 8 weeks for 24 weeks (3 doses) followed by a 24-week safety follow-up period. The primary outcome was change in daily average pain in the index bone metastasis cancer pain site (from 0 = no pain to 10 = worst possible pain) from baseline to week 8.

Results:

LS mean (SE) change in pain at week 8 was −1.25 (0.35) for placebo (n = 73) and –2.03 (0.35) for tanezumab 20 mg (n = 72). LS mean (SE) [95% CI] difference from placebo was –0.78 (0.37) [–1.52, –0.04]; P = .0381 with α = 0.0478. The number of subjects with a treatment-emergent adverse event during the treatment period was 50 (68.5%) for placebo and 53 (73.6%) for tanezumab 20 mg. The number of subjects with a prespecified joint safety event was 0 for placebo and 2 (2.8%) for tanezumab 20 mg (pathologic fracture; n = 2).

Conclusion:

Tanezumab 20 mg met the primary efficacy endpoint at week 8. Conclusions on longer-term efficacy are limited since the study was not designed to evaluate the durability of the effect beyond 8 weeks. Safety findings were consistent with adverse events expected in subjects with cancer pain due to bone metastasis and the known safety profile of tanezumab. Clinicaltrials.gov identifier: NCT02609828.

32

News (Medical) associated with Tanezumab

04 Jun 2025

·www.echemi.com

Eli Lilly Makes 1 Billion Dollar Bet on Opioid-Free Pain Relief with Bold SiteOne Acquisition

On May 27, Eli Lilly announced a strategic move to acquire SiteOne Therapeutics in a deal worth up to $1 billion, underscoring its commitment to expanding non-opioid pain therapies. The deal centers on STC-004, a Nav1.8 inhibitor that’s poised to enter Phase 2 clinical trials. Nav1.8 is an ion channel critical to pain signal transmission in the peripheral nervous system. By targeting this pathway, STC-004 offers hope for long-term relief from chronic pain without the addiction risks associated with opioids. Lilly will pay $300–400 million upfront, with the remainder tied to regulatory and commercial milestones. This acquisition strengthens Lilly’s pipeline beyond its current blockbuster drugs like tirzepatide for obesity and diabetes. Notably, Vertex Pharmaceuticals is the only company so far to have secured approval for a NaV1.8 inhibitor (Journavx), after past setbacks in the class. The path to non-opioid analgesics has been challenging. Vertex halted development of two similar candidates in 2020 before succeeding with one in later trials, though it failed to outperform Vicodin, a traditional opioid. Lilly has previously ventured into pain treatment, collaborating with Pfizer on tanezumab, a nerve growth factor (NGF) inhibitor. Despite initial promise in treating osteoarthritis, tanezumab was ultimately rejected by regulators over safety concerns. With the global opioid crisis intensifying, the industry is racing to develop safer, effective alternatives. If STC-004 can continue showing clinical promise, it may become a game-changer for millions suffering from chronic pain.

AcquisitionDrug ApprovalPhase 2

28 May 2025

·pharma.economictimes.indiatimes.com

Eli Lilly to buy SiteOne for $1 billion with eye on non-opioid pain drug

Bengaluru: Eli Lilly will buy privately held SiteOne Therapeutics in a deal worth as much as $1 billion, the companies said on Tuesday, giving the drugmaker access to an experimental non-opioid pain medicine. SiteOne's STC-004 will help Lilly expand its pipeline of drugs for chronic pain conditions such as migraine, as the pharma giant strives to get ahead in the race for alternatives to addictive opioid painkillers. STC-004 belongs to a class of drugs known as Nav1.8 inhibitors that targets the channels involved in transmitting pain signals. Opioids, on the other hand, trigger the brain's reward centers as they travel through the blood and then attach to neural receptors, leading to addiction and abuse. Vertex Pharmaceuticals' recently approved non-opioid painkiller Journavx is also a Nav1.8 inhibitor. Lilly's wider pain profile includes experimental drugs for diabetic peripheral neuropathic pain and to treat nerve pain that begins in the feet and moves up the leg to just below the knee. The SiteOne deal extends Lilly's trend of diversification beyond its recent success in obesity into therapeutic areas that the company knows well, said BMO Capital Markets analyst Evan Seigerman. Under the deal terms, SiteOne shareholders could get up to $1 billion in cash, including an upfront sum and subsequent payments when certain regulatory and commercial milestones are met. SiteOne is also studying other experimental drugs to treat conditions including pain and cough. For years, drugmakers have been trying and failing to bring new alternatives to opioid painkillers that have fueled a national addiction crisis in the U.S. Lilly and partner Pfizer discontinued the development of another non-opioid experimental drug, tanezumab, in 2021 after regulatory setbacks. In 2023, Lilly signed a deal with Confo Therapeutics to license its experimental non-opioid drug for neuropathic pain, a condition caused by damage to the nerves outside the brain and spinal cord. (Reporting by Sriparna Roy in Bengaluru; Editing by Devika Syamnath)

Drug Approval

28 May 2025

·pharma.economictimes.indiatimes.com

Eli Lilly to buy SiteOne for $1 billion with eye on non-opioid pain drug

Bengaluru: Eli Lilly will buy privately held SiteOne Therapeutics in a deal worth as much as $1 billion, the companies said on Tuesday, giving the drugmaker access to an experimental non-opioid pain medicine. SiteOne's STC-004 will help Lilly expand its pipeline of drugs for chronic pain conditions such as migraine, as the pharma giant strives to get ahead in the race for alternatives to addictive opioid painkillers. STC-004 belongs to a class of drugs known as Nav1.8 inhibitors that targets the channels involved in transmitting pain signals. Opioids, on the other hand, trigger the brain's reward centers as they travel through the blood and then attach to neural receptors, leading to addiction and abuse. Vertex Pharmaceuticals' recently approved non-opioid painkiller Journavx is also a Nav1.8 inhibitor. Lilly's wider pain profile includes experimental drugs for diabetic peripheral neuropathic pain and to treat nerve pain that begins in the feet and moves up the leg to just below the knee. The SiteOne deal extends Lilly's trend of diversification beyond its recent success in obesity into therapeutic areas that the company knows well, said BMO Capital Markets analyst Evan Seigerman. Under the deal terms, SiteOne shareholders could get up to $1 billion in cash, including an upfront sum and subsequent payments when certain regulatory and commercial milestones are met. SiteOne is also studying other experimental drugs to treat conditions including pain and cough. For years, drugmakers have been trying and failing to bring new alternatives to opioid painkillers that have fueled a national addiction crisis in the U.S. Lilly and partner Pfizer discontinued the development of another non-opioid experimental drug, tanezumab, in 2021 after regulatory setbacks. In 2023, Lilly signed a deal with Confo Therapeutics to license its experimental non-opioid drug for neuropathic pain, a condition caused by damage to the nerves outside the brain and spinal cord. (Reporting by Sriparna Roy in Bengaluru; Editing by Devika Syamnath)

Drug Approval

100 Deals associated with Tanezumab

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External Link

KEGG	Wiki	ATC	Drug Bank
D09387	Tanezumab	-	DB12335

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Osteoarthritis	NDA/BLA	European Union	Pfizer Europe MA EEIG	-
Bone metastases	Phase 3	United States	Pfizer Inc.	28 Oct 2015
Bone metastases	Phase 3	China	Pfizer Inc.	28 Oct 2015
Bone metastases	Phase 3	Japan	Huizhi Pharmaceutical (Dalian) Co., Ltd.	28 Oct 2015
Bone metastases	Phase 3	Japan	Pfizer Inc.	28 Oct 2015
Bone metastases	Phase 3	Argentina	Pfizer Inc.	28 Oct 2015
Bone metastases	Phase 3	Argentina	Huizhi Pharmaceutical (Dalian) Co., Ltd.	28 Oct 2015
Bone metastases	Phase 3	Australia	Huizhi Pharmaceutical (Dalian) Co., Ltd.	28 Oct 2015
Bone metastases	Phase 3	Australia	Pfizer Inc.	28 Oct 2015
Bone metastases	Phase 3	Austria	Huizhi Pharmaceutical (Dalian) Co., Ltd.	28 Oct 2015

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02528188 \| NCT02709486 \| NCT02697773 (Pubmed \| Osteoarthritis Cartilage)	Phase 3	Osteoarthritis	4,541	Tanezumab 2.5mg	zmxxjmmnoi(woaopydysy) = fexnjdynno vtkgsvxkbr (qlyzhshbae )	Positive	01 Dec 2023
				Tanezumab 5mg	zmxxjmmnoi(woaopydysy) = jetfqydbwq vtkgsvxkbr (qlyzhshbae )
NCT02528188 \| NCT02709486 \| NCT02697773 (pivotal phase III interventional studies, Pubmed \| CPT Pharmacometrics Syst Pharmacol)	Phase 3	nerve growth factor (NGF)	2,992	Tanezumab 2.5 mg	gelhnqowqm(rhvpejyxrj) = urtelkcsze vtcieyqasn (optpmqhjmw )	Positive	01 Sep 2023
NCT02609828 (CTgov)	Phase 3	Cancer Pain \| Bone metastases	156	placebo+tanezumab (Placebo)	itmdwcccib(jrcjaclztz) = juyzptkemq dgzdevfpdv (fthbnxxyfo, 0.35) View more	-	20 Jan 2023
				Tanezumab (Tanezumab 10 mg)	itmdwcccib(jrcjaclztz) = fpvwvowjqo dgzdevfpdv (fthbnxxyfo, NA) View more
NCT02528188 \| NCT02709486 \| NCT02697773 (NCT02528188 \| NCT02709486 \| NCT02697773, Pubmed \| Adv Ther)	Phase 3	Osteoarthritis	-	NSAIDs	wimapxttul(fsxkliczyy) = qlnvxyllvo trqpqhnhnm (ijazvocrtz )	-	01 Jan 2023
				Tanezumab 2.5 mg	wimapxttul(fsxkliczyy) = dsnhqziwtm trqpqhnhnm (ijazvocrtz )
NCT02528188 \| NCT02709486 \| NCT02697773 (Phase 3 trials of tanezumab, Pubmed \| Osteoarthr Imaging)	Phase 3	Osteoarthritis	-	Tanezumab	ilkrdloobm(muiojksrlg) = niyvrcgzra ydzkflioid (qkqdioxcrz )	-	01 Sep 2022
NCT02528188 \| NCT02709486 \| NCT02697773 (Pubmed)	Phase 3	Osteoarthritis, Hip \| Osteoarthritis, Knee	-	Tanezumab	varbxzxamn(kmjipgbedq) = ybtegievgh ryzkyznitq (ptaoziqgsy )	-	01 Mar 2022
NCT02528188 (Pubmed \| J Neurol Sci)	Phase 3	Osteoarthritis	3,021	Tanezumab 2.5mg	nhlqrsqtxl(wzxlqozagq) = fuhgrjtkig zhxxeajujx (hxpimmwebs ) View more	Positive	14 Feb 2022
				Tanezumab 5mg	nhlqrsqtxl(wzxlqozagq) = fvcftvmrse zhxxeajujx (hxpimmwebs ) View more
NCT02725411 (Pubmed)	Phase 3	Low Back Pain	277	Tanezumab 5 mg	jtrowoyoms(mvbqvfidhs) = gbuchcrjiv okzlhnahvo (nlhmxhzeve ) View more	-	17 Nov 2021
				Tanezumab 10 mg	jtrowoyoms(mvbqvfidhs) = mexqopcyhc okzlhnahvo (nlhmxhzeve ) View more
NCT02528188 (ACR2021)	Phase 3	Joint Loose Bodies	-	Tanezumab 2.5mg	bphffwlnmj(qfrwmiuvzo) = tkypkxqgth ebghyxrlfq (bprmdawgov ) View more	Positive	07 Nov 2021
				Tanezumab 5mg	bphffwlnmj(qfrwmiuvzo) = sywnavysjb ebghyxrlfq (bprmdawgov ) View more
NCT02528188 \| NCT02709486 \| NCT02697773 (ACR2021)	Phase 3	Osteoarthritis	4,541	Placebo	edpjtvccqg(tumvngevio) = qzgqxraeyi znqirqjvqf (xumuuzcxpn )	Negative	07 Nov 2021
				Tanezumab 2.5 mg	edpjtvccqg(tumvngevio) = heajkbbsgj znqirqjvqf (xumuuzcxpn )

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