A Phase 2 Randomized, Double-blind, Placebo-Controlled Study of the Analgesic Efficacy and Safety of the Subcutaneous Administration of the Anti-NGF Antibody Tanezumab in Subjects With Moderate to Severe Pain Due to Schwannomatosis

The primary objective of this study is to determine whether the administration of tanezumab, an anti-nerve growth factor (NGF) antibody, improves pain relief in schwannomatosis patients receiving background non-NSAID therapy.

Start Date30 Apr 2020

Sponsor / Collaborator

The General Hospital Corp.

[+1]

PER-069-15

/ RecruitingPhase 3

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER STUDY OF THE LONG- TERM SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE

Start Date01 Apr 2016

Sponsor / Collaborator-

NCT02709486

/ CompletedPhase 3

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE

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.

[+1]

100 Clinical Results associated with Tanezumab

100 Translational Medicine associated with Tanezumab

100 Patents (Medical) associated with Tanezumab

146

Literatures (Medical) associated with Tanezumab

01 May 2026·DRUGS

Efficacy and Safety of Anti-nerve Growth Factor Monoclonal Antibodies in Managing Chronic Musculoskeletal Pain: A Systematic Review with Network Meta-analysis

Review

Author: Mahgoub, Reham ; Alhasan, Mohammad ; Seah, K T Matthew ; Abouelella, Ahmed ; Ibrahim, Ayman ; Day, Richard O ; Arendt-Nielsen, Lars ; Najah, Qasi ; Al-Tamimi, Mansoor ; Bagg, Matthew K ; Elhadi, Muhammed ; Abuzied, Ola ; Lopez-Olivo, Maria A ; Hamoudah, Ahmed ; Basheer, Eman

BACKGROUND:

Anti-nerve growth factor (NGF) monoclonal antibodies (mAbs) have emerged as a promising new class of analgesics, offering potential benefits in managing particular painful musculoskeletal (MSK) conditions. However, their long-term safety remains uncertain, leading to regulatory non-approval of these agents. This study aims to evaluate the efficacy and safety of individual anti-NGF mAbs compared to other analgesics when treating chronic MSK pain.

METHODS:

Our literature search included PubMed, Scopus, Embase, Web of Science, Cochrane Library, and ClinicalTrials.gov through April 25th, 2025. Articles eligible for inclusion were randomized controlled trials (RCTs) comparing one of the human anti-NGF mAbs to other interventions in adults with chronic MSK pain. Primary outcomes evaluated were changes from baseline in pain, physical function, and patient global assessment (PGA) scores, as well as risks of adjudicated arthropathies (AAs) and abnormal peripheral sensation (APS). We used the Cochrane Risk of Bias 2 (RoB-2) tool to assess risk of bias. Pairwise and network meta-analyses were performed using random-effects models. Treatments were ranked using the cumulative ranking curve (SUCRA), and a multi-criteria decision analysis with Technique for Order Preference by Similarity to Ideal Solution (TOPSIS) was applied to integrate all efficacy and safety outcomes. Statistical analyses were conducted in R (v4.3.1) using the meta, netmeta, gemtc, and Multi-Criteria Decision Aiding (MCDA) packages.

RESULTS:

A total of 29 studies, involving 27,747 patients with osteoarthritis or chronic low back pain, were included in this analysis. Compared to placebo, fasinumab showed the highest improvements in pain (standardized mean difference [SMD] - 0.40, 95% CI [- 0.52, - 0.29], p < 0.001) and physical function (SMD - 0.42, 95% CI [- 0.53, - 0.31], p < 0.001), followed by tanezumab (pain: SMD - 0.36, 95% CI [- 0.44, - 0.28], p < 0.001; function: SMD - 0.39, 95% CI [- 0.47, - 0.31], p < 0.001). For safety, both fasinumab and tanezumab demonstrated a significant risk for AAs (risk ratio [RR] 4.7, 95% CI [3.61, 6.13], p < 0.001; and RR 3.84, 95% CI [2.07, 7.14], p < 0.001, respectively) and APS (RR 1.99, 95% CI [1.49, 2.65], p < 0.001; and RR 2.46, 95% CI [1.93, 3.14], p < 0.001, respectively) relative to placebo. While fulranumab was less effective (pain: SMD - 0.25, 95% CI [- 0.42, - 0.07], p < 0.01; function: SMD - 0.25, 95% CI [- 0.43, - 0.07], p < 0.01), it showed better overall safety against placebo relative to both agents, demonstrating a significant risk only for APS events (RR 1.78, 95% CI [1.09, 2.92], p < 0.05).

CONCLUSIONS:

Anti-NGF mAbs, particularly fasinumab and tanezumab, are associated with the greatest levels of pain relief and functional improvement over placebo within this analysis. However, these benefits are counterbalanced by significant risks of joint-related adverse events. Implementation of strict safety protocols is essential when considering these agents for further evaluation.

PROTOCOL REGISTRATION:

PROSPERO ID: CRD420251104612.

01 Jan 2026·Scandinavian Journal of Pain

Analgesic, anti-inflammatory and joint protective effects of ACD137, a selective negative allosteric modulator of TrkA, in models of chemotherapy-induced peripheral neuropathy and osteoarthritis.

Article

Author: Segerdahl, Märta ; Backlund, Maria ; Forsell, Pontus ; Fernandez, Cristina Parrado ; Nordvall, Gunnar ; Sandin, Johan ; Lidell, Veronica ; Rasti, Azita

OBJECTIVES:

The neurotrophin receptor TrkA is a clinically and genetically validated target in pain signaling. Anti-nerve growth factor (NGF) monoclonal antibodies have shown clinical efficacy but with side effects such as rapidly progressing osteoarthritis limiting their use, potentially mediated via inhibition of NGF/p75NTR signaling. Therefore, we sought to identify novel and selective small molecule negative allosteric modulators of tropomyosin receptor kinase A (TrkA) and to verify their analgesic effect in vivo.

METHODS:

We have identified ACD137 as a potent and selective negative allosteric modulator (NAM) of TrkA during a lead optimization program. The potency of ACD137 on TrkA and selectivity over TrkB was determined in cell-based assays. ACD137 was tested for its analgesic and anti-inflammatory effects in a model of chemotherapy induced peripheral neuropathy (CIPN) using paclitaxel and in the mono-iodo acetate (MIA)-induced osteoarthritis model in rats.

RESULTS:

ACD137 demonstrated an IC₅₀-value on TrkA of 1.2 nM and showed approximately 17,300- and 17,600-fold selectivivity for TrkA over TrkB and TrkC, respectively. After oral administration in rats, ACD137 reduced mechanical allodynia in the CIPN model in a dose-dependent manner with maximal analgesic efficacy similar to the effect of gabapentin. In a comparative arthritis study using the anti-NGF antibody tanezumab as comparator, ACD137 reduced both evoked and non-evoked pain behavior as well as inflammation with similar efficacy as tanezumab. Surprisingly, ACD137 demonstrated a significant protective effect against knee joint deterioration, something that was not observed with tanezumab.

CONCLUSIONS:

The data demonstrates that ACD137 is a potent, selective and in vivo active negative allosteric modulator of TrkA exhibiting analgesic effects in models of neuropathic and nociceptive pain. The molecule possesses promising properties for further pre-clinical development.

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.

News (Medical) associated with Tanezumab

06 May 2026

·www.biospace.com

New scientific Article Published on TrkA-NAM ACD137 Against Osteoarthritic Pain

STOCKHOLM, SE / ACCESS Newswire / May 6, 2026 / AlzeCure Pharma AB (publ) (STO:ALZCUR)(FRA:AC6), a biotech company that develops candidate drugs for diseases affecting the nervous system, focusing on Alzheimer's disease and pain, today announced that a scientific article has been published on the preclinical characterization of ACD137, the lead drug candidate in the TrkA-NAM pain project. The scientific article, titled Analgesic, anti-inflammatory and joint protective effects of ACD137, a selective negative allosteric modulator of TrkA, in models of chemotherapy-induced peripheral neuropathy and osteoarthritis , has been published online in the Scandinavian Journal of Pain and is written by Pontus Forsell, PhD and Head of Discovery & Research at AlzeCure Pharma. Co-authors are Maria Backlund, Veronica Lidell, Azita Rasti, Cristina Parrado Fernandez, Märta Segerdahl, Johan Sandin and Gunnar Nordvall. The article describes how the lead drug candidate in the TrkA-NAM project, Painless ACD137, was developed and characterized. Data from the preclinical studies show that the substance is highly potent and selective, with good properties for further development as a drug. ACD137 mediates its effects by blocking NGF-mediated signaling via TrkA receptors, a biological mechanism with strong genetic, preclinical and clinical validation for its role in pain. The substance has potent analgesic effects in several different preclinical pain models, both in neuropathic pain and in models of osteoarthritis-related pain. The analgesic effect of ACD137 has been shown in a comparative study to be as effective as the anti-NGF antibody Tanezumab, which has demonstrated significant and robust pain relief in several large clinical trials. Furthermore, anti-inflammatory and protective effects on the knee joint were observed, indicating a disease-modifying effect and which has great potential value in patients with osteoarthritis. "This article describes how we have worked in our TrkA-NAM program to identify the highly potent and selective TrkA-NAM compound, ACD137. The compound has potent analgesic effects in preclinical in vivo models, both in neuropathic and nociceptive pain, indicating multiple applications in pain relief. Due to the selective mechanism of action, we also expect a much better safety pro this class of compounds compared to anti-NGF antibodies," said Pontus Forsell, project leader and Head of Discovery & Research at AlzeCure Pharma. "We are very pleased and proud of the results presented in this scientific publication. There is a significant and growing interest in our TrkA-NAM program among external stakeholders, especially since the mechanism of action has not shown the side effects and addiction problems observed with opioids. In addition, the medical need is very large and growing. Today, it is estimated that over 600 million people suffer from painful osteoarthritis*," said Martin Jönsson, CEO of AlzeCure Pharma. The article is now available online via the following link: *) Global, regional, and national burden of osteoarthritis, 1990-2020 and projections to 2050: a systematic analysis for the Global Burden of Disease Study 2021; The Lancet, Volume 5, Issue 9, 2023 For more information, please contact Martin Jönsson, CEO Tel: +46 707 86 94 43 martin.jonsson@alzecurepharma.com About AlzeCure Pharma AB (publ) AlzeCure ® is a Swedish clinical stage biotech company that develops new innovative drug therapies for the treatment of severe diseases and conditions that affect the central nervous system, such as Alzheimer's disease and pain - indications for which currently available treatment is very limited. The company is listed on Nasdaq First North Premier Growth Market and is developing several parallel drug candidates based on three research platforms: NeuroRestore ® , Alzstatin ® and Painless. NeuroRestore consists of one symptomatic drug candidate where the unique mechanism of action allows for multiple indications, including Alzheimer's disease, as well as cognitive disorders associated with traumatic brain injury, sleep apnea and Parkinson's disease. NeuroRestore has received an EU grant from the European Innovation Council and is being prepared for phase 2. Alzstatin focuses on developing disease-modifying and preventive drug candidates for early treatment of Alzheimer's disease. Painless contains two projects: ACD440, which is a drug candidate for the treatment of neuropathic pain with positive phase 2 results and orphan drug designation from the FDA in the USA and from EMA in Europe for the rare pain disease erythromelalgia, and TrkA-NAM, which targets severe pain in conditions such as osteoarthritis. AlzeCure aims to pursue its own projects through preclinical research and development through an early clinical phase, and is continually working on business development to find suitable outlicensing solutions with other pharmaceutical companies. FNCA Sweden AB is the company's Certified Adviser. For more information, please visit . Image Attachments Martin Jönsson CEO And Pontus Forsell Head Of D&R AlzeCure Pharma Attachments New scientific article published on TrkA-NAM ACD137 against osteoarthritic pain SOURCE: AlzeCure Pharma View the original press release on ACCESS Newswire

Phase 2Orphan Drug

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

100 Deals associated with Tanezumab

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	China	Pfizer Inc.	28 Oct 2015
Bone metastases	Phase 3	Japan	Pfizer Inc.	28 Oct 2015
Bone metastases	Phase 3	Japan	Huizhi Pharmaceutical (Dalian) Co., Ltd.	28 Oct 2015
Bone metastases	Phase 3	Argentina	Huizhi Pharmaceutical (Dalian) Co., Ltd.	28 Oct 2015
Bone metastases	Phase 3	Argentina	Pfizer Inc.	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
Bone metastases	Phase 3	Austria	Pfizer Inc.	28 Oct 2015

Clinical Result

Indication

Phase

Evaluation

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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	kocgftstkx(aynhrunmvm) = nucfwpqhpr gztznhswpk (pygiroxeyo )	Positive	01 Dec 2023
				Tanezumab 5mg	kocgftstkx(aynhrunmvm) = zqatjpdazc gztznhswpk (pygiroxeyo )
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	exgfaxecdu(tgmujhvqlz) = vvqzrdfcfs natvaaieqi (sixnjpyhjx )	Positive	01 Sep 2023
NCT02609828 (CTgov)	Phase 3	Cancer Pain \| Bone metastases	156	placebo+tanezumab (Placebo)	dqcocunmtn(ebzitqbode) = iampxgtqgw nvfqxseavr (gzpfuvddob, 0.35) View more	-	20 Jan 2023
				Tanezumab (Tanezumab 10 mg)	dqcocunmtn(ebzitqbode) = lfwvwlniql nvfqxseavr (gzpfuvddob, NA) View more
NCT02528188 \| NCT02709486 \| NCT02697773 (NCT02528188 \| NCT02709486 \| NCT02697773, Pubmed \| Adv Ther)	Phase 3	Osteoarthritis	-	NSAIDs	imkouzwuin(rtlbzspwqm) = vhkkerduib jcqkwhraqi (ntwagnaiwm )	-	01 Jan 2023
				Tanezumab 2.5 mg	imkouzwuin(rtlbzspwqm) = czbceczpum jcqkwhraqi (ntwagnaiwm )
NCT02528188 \| NCT02709486 \| NCT02697773 (Phase 3 trials of tanezumab, Pubmed \| Osteoarthr Imaging)	Phase 3	Osteoarthritis	-	Tanezumab	cdkztxmzum(gskfqvoxmy) = ehrvkihfga poeindfggy (oaqmlvpqwa )	-	01 Sep 2022
NCT02528188 \| NCT02709486 \| NCT02697773 (Pubmed)	Phase 3	Osteoarthritis, Hip \| Osteoarthritis, Knee	-	Tanezumab	zvxpseuzru(euldhzdiea) = pevjiqbdbl derebsurir (lnuukwrcrn )	-	01 Mar 2022
NCT02528188 (Pubmed \| J Neurol Sci)	Phase 3	Osteoarthritis	3,021	Tanezumab 2.5mg	kelqrmtxbv(wqeaejuttd) = barbffmhcd xmpeoashxz (djlndsuuwu ) View more	Positive	14 Feb 2022
				Tanezumab 5mg	kelqrmtxbv(wqeaejuttd) = htabopscsh xmpeoashxz (djlndsuuwu ) View more
NCT02725411 (Pubmed)	Phase 3	Low Back Pain	277	Tanezumab 5 mg	mxepzbkqpm(dcbjkwfogw) = rtomqoemzg cajpvttjur (xurlfquvqf ) View more	-	17 Nov 2021
				Tanezumab 10 mg	mxepzbkqpm(dcbjkwfogw) = vlucygeydf cajpvttjur (xurlfquvqf ) View more
NCT02528188 (ACR2021)	Phase 3	Joint Loose Bodies	-	Tanezumab 2.5mg	olfudolwil(cbviranxzx) = mfvhqppsuq qxddidrihs (tcojbvtymj ) View more	Positive	07 Nov 2021
				Tanezumab 5mg	olfudolwil(cbviranxzx) = gctlisuoic qxddidrihs (tcojbvtymj ) View more
NCT02528188 \| NCT02709486 \| NCT02697773 (ACR2021)	Phase 3	Osteoarthritis	4,541	Placebo	lzppclnpuh(kytpebdhfd) = ltskrvcmac hclghtasky (xrgceebpff )	Negative	07 Nov 2021
				Tanezumab 2.5 mg	lzppclnpuh(kytpebdhfd) = odiylctqju hclghtasky (xrgceebpff )

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