This is a research study to find out if Qutenza 8% capsaicin topical system is safe and effective when treating subjects with lower back pain (LBP) that is caused by damage at or near the nerve's root in the lower back leg (lumbosacral radiculopathy) which is pain that can move all the way down the back of the leg. The pain may also start outside of the spinal cord, in the peripheral nerves and may also be felt all the way down the back of the leg (neuropathic LBP). Qutenza 8% capsaicin, the study drug, is currently FDA approved to treat nerve pain after a shingles outbreak in addition to a type of nerve pain in the feet associated with diabetes. In this study a maximum of four patches per visit (sized 14cm x 20 cm) will be used to deliver the Qutenza 8% capsaicin to the participants skin.
If a subject meets the qualifications for this study, in addition to their standard of care for their LBP, they can expect to have a total of 5 visits in a 12 month period. Each visit will require subjects to fill out several surveys and receive treatment patches for their LBP (your doctor will decide if participants will need to be retreated at each visit based on your symptoms). The study visits are estimated to take 90 minutes upwards to 120 minutes.

Start Date31 Jan 2025

Sponsor / Collaborator

Medical University of South Carolina

[+1]

TCTR20241008002

/ Not yet recruitingPhase 1/2IIT

Efficacy of Capsaicin Nasal Spray in Non-allergic rhinitis : A pilot study

Start Date01 Jan 2025

Sponsor / Collaborator

Faculty of Medicine Siriraj Hospital

100 Clinical Results associated with Capsaicin

100 Translational Medicine associated with Capsaicin

100 Patents (Medical) associated with Capsaicin

12,740

Literatures (Medical) associated with Capsaicin

01 Mar 2025·Biosensors and Bioelectronics

Development of a dual-mode lateral flow assay based on structure-guided aptamers for the detection of capsaicin in gutter oils

Article

Author: Chen, Peifang ; Yang, Junsong ; Ding, Ning ; Li, Yu ; Wang, Zhouping ; Qin, Mingwei ; Jiang, Hongtao ; Ma, Pengfei

The construction of structure-guided aptamers and the ultra-sensitive aptamer-based lateral flow assays (Apt-LFA) integrated detection method hold significant potential for food analysis. Using an engineered modified sequence strategy, we successfully developed the aptamer Cap-1-2M4, significantly enhancing its affinity for capsaicin (CAP) to 0.6197 ± 0.0689 nM. We developed a highly sensitive method for CAP detection based on Vap@AuNFs, leveraging their superior colorimetric and photothermal signals and high aptamer coupling performance. The Vap@AuNFs-based Apt-LFA (Vap@AuNFs-Apt-LFA) achieve signal amplification through catalytic hairpin assembly (CHA) and exonuclease III (Exo III). Additionally, dual-mode (colorimetric and photothermal) quantitative detection via lateral flow test strips was achieved by capturing the nucleic acid effect of Vap@AuNFs. The limit of detection (LOD) of Vap@AuNFs-Apt-LFA by colorimetric/photothermal method was 0.043 ng mL^-1 and 0.011 ng mL^-1, with linear ranges of 0.1-500 ng mL^-1 and 0.05-500 ng mL^-1, respectively. This aptamer engineering strategy and the developed Vap@AuNFs-Apt-LFA offer new directions for food safety and provide a reference for feasible portable detection methods.

01 Mar 2025·Food Chemistry

Time-resolved fluorescence/visual dual-readout nanobiosensors for the detection of aflatoxin B1, benzo(α)pyrene and capsaicin in edible oils using a miniaturized paper analytical device

Article

Author: Lu, Baiyi ; Huang, Xiaorong ; Li, Peiwu ; Tang, Xiaoqian ; Zhang, Qi

Edible oil safety impacts food safety and consumer health. The typical pollutants-aflatoxin B₁ (AFB₁) and benzo(α)pyrene (BaP), and kitchen waste oil-are significant hazards in edible oil consumption. Herein, we developed a dual-readout lateral flow immunoassay (tdLFIA) for the multi-quantitative detection of AFB₁, BaP and capsaicin (CAP). A novel monoclonal antibody against BaP was developed with a sensitivity of 1.92 ng/mL. Subsequently, gold nanoparticles and Eu³⁺ labelled fluorescent nanospheres were synthesized as colorimetric and fluorescent sensors. A rapid synchronous pretreatment method based on immunomagnetic beads(IMAB)combined with a molecularly imprinted solid phase extraction (MISPE) was developed. The tdLFIA enabled a rapid response of 7 min for AFB₁, BaP and CAP detection, with quantitative limits of detection of 0.003, 0.6, and 0.01 ng/mL, respectively. The proposed strategy indicated reliability and has been applied in real samples, providing useful products for evaluating edible oil quality and safety.

01 Mar 2025·Microbial Pathogenesis

Polydimethylsiloxane loaded capsaicin afflicts membrane integrity, metabolic activity and biofilm formation of nosocomial pathogens

Article

Author: Padmavathi, Alwar Ramanujam ; Rao, Toleti Subba ; Murthy, P Sriyutha ; Karthikeyan, B ; Senthil Kumar, J

Biofilms constitute 80 % of all nosocomial infections associated with invasive medical devices. Polydimethylsiloxane, a highly elastic, inert, non-reactive, biocompatible silicone polymer is widely used as implant biomaterial due to its non-toxic and low-immunogenic nature. Owing to its hydrophobicity, PDMS suffers from microbial adhesion. Inhibition of biofilm formation on PDMS surfaces is imperative to prevent morbidity, mortality and replacement of implants. The present study investigates the efficacy of capsaicin (0.5 % w/v) loaded PDMS as a broad spectrum antimicrobial surface against Staphylococcus aureus, Escherichia coli and Candida albicans. Capsaicin exhibited minimum inhibitory concentration of 1024 μg mL^-1 for S. aureus, E. coli and 256 μg mL^-1 for C. albicans. Capsaicin inhibited biofilms of S. aureus, E. coli and C. albicans at much lower concentrations of 2, 64 and 8 μg mL^-1 respectively. The minimum capsaicin concentrations required for total biofilm eradication was found to be 256, 512, 128 μg mL^-1 for S. aureus, E. coli and C. albicans respectively. Probing sub-lethal concentrations of capsaicin revealed 38, 32, 30 % reduction in metabolic activity of S. aureus, E. coli & C. albicans planktonic cells respectively. Similarly, there was an increase in permeability of cells to propidium iodide compared to control. By reducing the metabolic activity and perturbing membrane integrity, capsaicin could prevent biofilm formation and this was also observed with capsaicin-PDMS surfaces that exhibited 1 log (∼90 %) reduction of viable bacterial counts.

News (Medical) associated with Capsaicin

07 Nov 2024

·www.prnewswire.com

Grünenthal and Averitas Pharma announce completion of recruitment for Phase III clinical trial with QUTENZA® in post-surgical neuropathic pain

The Phase III trial AV001 aims to evaluate QUTENZA® in post-surgical neuropathic pain (PSNP), a debilitating complication of surgery occurring after approximately 10 percent of all surgical procedures1, thus affecting more than 3 million people with surgical procedures per year in the U.S.2 QUTENZA® is a topical system, non-systemic, non-opioid pain treatment that is currently approved in the US for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults. Topline results are expected in Q4 2025, and Averitas Pharma aims to submit a supplemental new drug application (sNDA) for a US label extension in 2026, subject to positive data. AACHEN, Germany and MORRISTOWN, N.J., Nov. 7, 2024 /PRNewswire/ -- Grünenthal announced today that its U.S. subsidiary, Averitas Pharma, Inc., has completed recruitment for the Phase III clinical trial AV001. The trial investigates the efficacy, safety and tolerability of QUTENZA® (capsaicin) 8% topical system in post-surgical neuropathic pain (PSNP) and if successful could support an extension of the U.S. label. "Patients who undergo surgery and end up developing post-surgical neuropathic pain, may experience debilitating complications that often are not treated appropriately," says Lizandra Marcondes, M.D., PhD, Senior VP Medical Affairs & Drug Safety US, Averitas Pharma. "We believe QUTENZA® may be a clinically meaningful treatment option that could address the unmet needs of many patients in the United States who suffer from Post-surgical neuropathic pain and may not be satisfied with available oral, systemically acting medicines. We look forward to completing the Clinical Trial with the goal to file a supplemental new drug application to the U.S. Food and Drug Administration (FDA) in 2026, assuming positive data." AV001 is a randomized, double-blind 42-week trial including 410 patients who have been suffering from moderate to severe PSNP for at least six months. The primary endpoint of the trial is a reduction in the average pain intensity after 12 weeks compared to baseline. In addition, the trial assesses other outcomes including reduction in the average pain intensity after 42-weeks, progressive response over time with repeated treatment, reduction of the treatment area over several applications, and quality of life outcomes such as sleep interference, physical activity, anxiety, and depression. When completed, AV001 will be the first blinded randomized controlled trial in post-surgical neuropathic pain that evaluates the long-term treatment effects of a topical neuropathic pain treatment. "The completion of enrollment is an exciting milestone. With our current indications, adults with painful diabetic peripheral neuropathy of the feet and postherpetic neuralgia, we have advanced the trajectory of QUTENZA® in the U.S. by expanding access to a much-needed non-opioid therapy option for a large, underserved patient population," adds Marv Kelly, President Averitas Pharma. "By adding post-surgical neuropathic pain to the U.S. label if results are positive, we would have the potential to fill an unmet treatment need for additional patients in pain." When Grünenthal acquired the US-rights for Qutenza® in 2018, the US-label comprised the treatment of neuropathic pain associated with postherpetic neuralgia. Since then, Grünenthal re-launched the product and significantly increased patients' access to Qutenza®. In 2020, the U.S. FDA approved the product for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults. With AV001, Grünenthal and Averitas hope to include another major indication in the field of peripheral neuropathic pain in the U.S. label. Topline results are anticipated in Q4 2025 and, assuming positive data, Averitas Pharma aims to submit a supplemental new drug application (sNDA) in 2026. About QUTENZA QUTENZA (capsaicin) 8% topical system is approved in the US for the treatment of neuropathic pain associated with postherpetic neuralgia, and for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults. Important U.S. safety information is available below and at . In Europe, QUTENZA is indicated for the treatment of peripheral neuropathic pain in adults either alone or in combination with other medicinal products for the treatment of pain. For further information please visit . About post-surgical neuropathic pain Post-surgical neuropathic pain (PSNP) is defined as chronic pain that develops after a surgical procedure and persists beyond the healing process, i.e., at least three months after the surgery. The pain is either localized to the surgical field or area of injury, projected to the innervation territory of a nerve situated in this area, or referred to a dermatome (after surgery/injury to deep somatic or visceral tissues).3 It is identified by symptoms of neuropathic nerve pain such as burning, stabbing or shooting pain, numbness, and changes to physical sensation or sensitivity to temperature or touch. PSNP occurs after approximately 10 percent of all surgical procedures1, thus affecting more than 3 million people with surgical procedures per year in the U.S.2 About Averitas Pharma, Inc. Averitas Pharma is a specialty pharmaceutical company dedicated to delivering innovative, effective, non-opioid pain management options to patients in the U.S. The company was formed in 2018 as a subsidiary of GRT U.S. Holding, Inc. and member of the Grünenthal Group. For more information, visit . Follow us on LinkedIn: About Grünenthal Grünenthal is a global leader in pain management and related diseases. As a science-based, fully integrated pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We are focusing all our activities and efforts on working towards our vision of a World Free of Pain. Grünenthal is headquartered in Aachen, Germany, and has affiliates in 27 countries across Europe, Latin America, and the U.S. Our products are available in approx. 100 countries. In 2023, Grünenthal employed around 4,400 people and achieved revenues of €1.8 billion. More information: Follow us on: LinkedIn: Grunenthal Group Instagram: grunenthal For further information, please contact: Christopher Jansen, Global Corporate Affairs Phone: +49 241 569-1428 [email protected] Florian Dieckmann, Head Global Corporate Affairs Phone: +49 241 569-2555 [email protected] IMPORTANT US-SAFETY INFORMATION Do not dispense QUTENZA to patients for self-administration or handling. Use only on dry, unbroken skin. Only physicians or healthcare professionals are to administer and handle QUTENZA, following the procedures in the label. Warnings and Precautions Severe Irritation: Whether applied directly or transferred accidentally from other surfaces, capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin to the healthcare professional, patients, and others. Do not use near eyes or mucous membranes, including face and scalp. Take protective measures, including wearing nitrile gloves and not touching items or surfaces that the patient may also touch. Flush irritated mucous membranes or eyes with water and provide supportive medical care for shortness of breath. Remove affected individuals from the vicinity of QUTENZA. Do not re-expose affected individuals to QUTENZA if respiratory irritation worsens or does not resolve. If skin not intended to be treated comes into contact with QUTENZA, apply Cleansing Gel and then wipe off with dry gauze. Thoroughly clean all areas and items exposed to QUTENZA and dispose of properly. Because aerosolization of capsaicin can occur with rapid removal, administer QUTENZA in a well-ventilated area, and remove gently and slowly, rolling the adhesive side inward. Application-Associated Pain: Patients may experience substantial procedural pain and burning upon application and following removal of QUTENZA. Prepare to treat acute pain during and following application with local cooling and/or appropriate analgesic medication. Increase in Blood Pressure: Transient increases in blood pressure may occur with QUTENZA treatment. Monitor blood pressure during and following treatment procedure and provide support for treatment-related pain. Patients with unstable or poorly controlled hypertension, or a recent history of cardiovascular or cerebrovascular events, may be at an increased risk of adverse cardiovascular effects. Consider these factors prior to initiating QUTENZA treatment. Sensory Function: Reductions in sensory function (generally minor and temporary) have been reported following administration of QUTENZA. Assess for signs of sensory deterioration or loss prior to each application of QUTENZA. If sensory loss occurs, treatment should be reconsidered. Severe Application Site Burns: Full-thickness (third-degree) and deep partial-thickness (second-degree) burns have been reported following administration of QUTENZA. Cases of full-thickness (third-degree) burns, requiring hospitalization and skin grafting have been reported in patients who received QUTENZA for an unapproved indication and/or frequency of dosing at an application site where there had been prior skin trauma. Ensure that dosage and administration recommendations are followed. Adverse Reactions The most common adverse reactions (≥5% and > control group) in all controlled clinical trials are application site erythema, application site pain, and application site pruritus. To report SUSPECTED ADVERSE REACTIONS, contact Averitas Pharma, Inc. at 1-877-900-6479 or FDA at 1-800-FDA-1088 or . Please see full Prescribing Information. 1 Rosenberger DC, Pogatzki-Zahn EM. Chronic post-surgical pain - update on incidence, risk factors and preventive treatment options. BJA Educ. 2022 May;22(5):190-196. doi: 10.1016/j.bjae.2021.11.008. Epub 2022 Feb 24. 2 (Accessed November 2024) 3 ICD 11 - SOURCE Grünenthal Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug Approval

22 Oct 2024

·pipelinereview.com

First participants enrolled in first-in-human Phase I clinical trial with nociceptin (NOP) receptor agonist

AACHEN, Germany I October 22, 2024 I Today, Grünenthal announced that the first participants have been enrolled in a first-in-human Phase I clinical trial for a nociceptin (NOP) receptor agonist. The trial will include 90 healthy volunteers and aims to demonstrate a favourable safety and tolerability profile and to confirm the pharmacokinetic characteristics of the compound after single and multiple ascending doses. The results of the trial are expected in Q3 2025. “Grünenthal pioneered the research into NOP receptor agonists to deliver a unique and transformative first-in-class therapy option to millions of patients suffering from chronic pain,” says Gillian Burgess, Head of Research, Grünenthal. “With a unique mechanism of action for treating chronic pain, these molecules have the potential to deliver robust pain relief combined with an improved safety profile compared to the available standard of care.” Pre-clinical data show that NOP receptor agonists have the potential to act as potent analgesics without abuse liability. 1 Leveraging the clinical data Grünenthal obtained during the development of its NOP receptor programme, Grünenthal now brings forward a candidate that shows best-in-class potency and selectivity for the NOP receptor. These properties are predicted to provide robust pain relief in a broad range of chronic pain indications without the serious central nervous system related side effects associated with available opioids. Grünenthal’s R&D pipeline includes multiple programmes across different stages, targets, modalities, and mechanisms of action to deliver innovative treatment options for patients suffering from pain and related diseases. Recently, a Phase I clinical trial with a Glucocorticoid Receptor Modulator (GRM) has been completed. The compound is developed to provide patients with a therapy option for chronic inflammatory diseases. In addition, Grünenthal is running a Phase III clinical trial with Qutenza ® (capsaicin) 8% topical system in post-surgical neuropathic pain, aiming to expand its label in the United States. A global Phase III programme investigating the efficacy, safety and tolerability of Resiniferatoxin in patients with painful osteoarthritis of the knee is currently ongoing. About the NOP Receptor The nociceptin (NOP) receptor is a G protein-coupled receptor whose natural ligand is the 17 amino acid neuropeptide known as nociceptin (N/OFQ). 2 NOP Receptor agonists have been shown to act as potent analgesics without abuse liability in pre-clinical models. 1 Although the NOP Receptor shares some sequence identity (~60%) with the opioid receptors μ-OP (MOP), κ-OP (KOP), and δ-OP (DOP), they possess little or no affinity for opioid peptides or morphine-like compounds. Likewise, opioid receptors possess little affinity towards NOP’s endogenous ligand nociceptin. 3 About Grünenthal Grünenthal is a global leader in pain management and related diseases. As a science-based, fully integrated pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We are focusing all our activities and efforts on working towards our vision of a World Free of Pain. Grünenthal is headquartered in Aachen, Germany, and has affiliates in 27 countries across Europe, Latin America, and the U.S. Our products are available in approx. 100 countries. In 2023, Grünenthal employed around 4,400 people and achieved revenues of €1.8 billion. More information: https://www.grunenthal.com Follow us on: LinkedIn: Grunenthal Group Instagram: grunenthal 1 Lin AP, Ko MC. The therapeutic potential of nociceptin/orphanin FQ receptor agonists as analgesics without abuse liability. ACS Chem Neurosci. 2013 Feb 20;4(2):214-24. doi: 10.1021/cn300124f. Epub 2012 Nov 6. PMID: 23421672; PMCID: PMC3582300. 2 Henderson G, McKnight AT (August 1997). “The orphan opioid receptor and its endogenous ligand– nociceptin/orphanin FQ”. Trends in Pharmacological Sciences. 18 (8): 293–300. doi:10.1016/S0165- 6147(97)90645-3. PMID 9277133. 3 Butour JL, Moisand C, Mazarguil H, Mollereau C, Meunier JC (February 1997). “Recognition and activation of the opioid receptor-like ORL 1 receptor by nociceptin, nociceptin analogs and opioids”. European Journal of Pharmacology. 321 (1): 97–103. doi:10.1016/S0014-2999(96)00919-3. PMID 9083791. SOURCE: Grünenthal Group

Phase 1Phase 3Phase 2

28 Aug 2024

·www.prnewswire.com

Peripheral Neuropathic Pain Market to Exhibit Growth at a CAGR of 4.1% by 2034 | DelveInsight

The increasing cases of peripheral neuropathic pain, rise in screening for diabetic neuropathic pain among diabetics, increase in the geriatric population, and launch of new approved drugs, among other reasons are likely to fuel the growth of the peripheral neuropathic pain market size during the forecast period (2024–2034). LAS VEGAS, Aug. 28, 2024 /PRNewswire/ --DelveInsight's Peripheral Neuropathic Pain Market Insights report includes a comprehensive understanding of current treatment practices, peripheral neuropathic pain emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Peripheral Neuropathic Pain Market Report According to DelveInsight's analysis, the market size for peripheral neuropathic pain was found to be ~ USD 12 billion in the 7MM in 2023. The United States accounts for the largest market size of PNP in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan. The total cases of peripheral neuropathic pain in the 7MM were approximately 60 million cases in 2023, which are expected to increase during the study period (2020–2034). Leading peripheral neuropathic pain companies such as Lexicon Pharmaceuticals, Merz Therapeutics, Apurano Pharmaceuticals, Vertex Pharmaceuticals, WEX Pharmaceuticals, Scilex Holding Company, and others are developing novel peripheral neuropathic pain drugs that can be available in the peripheral neuropathic pain market in the coming years. The promising peripheral neuropathic pain therapies in the pipeline include LX9211, XEOMIN (incobotulinumtoxinA), Adezunap (AP707), Suzetrigine (VX-548), HALNEURON (Tetrodotoxin or TTX), SEMDEXA (SP-102), and others. Compared to all the emerging therapies, LX9211 and SEMDEXA are expected to become the market leader, having a major influence on the peripheral neuropathic pain market of the 7MM by 2034. In November 2023, Lexicon Pharmaceuticals announced that it has enrolled the first patient in PROGRESS (A Phase IIb, dose-ranging, randomized, double-blind, placebo-controlled, parallel-group, multicenter study with an open-label extension in patients with diabetic peripheral neuropathic pain) studying LX9211. Discover which therapies are expected to grab the major peripheral neuropathic pain market share @ Peripheral Neuropathic Pain Market Report Peripheral Neuropathic Pain Overview Peripheral neuropathies refer to conditions affecting peripheral nerve cells and fibers, arising from a variety of underlying causes. These nerves include the cranial nerves, spinal nerve roots and ganglia, nerve trunks and divisions, and the autonomic nervous system nerves. Peripheral neuropathies can be classified in several ways, such as mononeuropathies, multifocal neuropathies, and polyneuropathies. Mononeuropathy involves damage to a single nerve, while multiple mononeuropathy affects two or more nerves in different locations. Polyneuropathy typically impacts many or most nerves. The diversity of symptoms associated with peripheral neuropathy allows for the identification of distinct clinical phenotypes, which is important for guiding the diagnostic process. Nerve conduction studies are crucial for determining the phenotype and assessing severity. Additional diagnostic tools, such as laboratory tests, genetic testing, cerebrospinal fluid examination, nerve imaging, and nerve biopsy, may be useful in specific clinical situations. Peripheral Neuropathic Pain Epidemiology Segmentation The peripheral neuropathic pain epidemiology section provides insights into the historical and current peripheral neuropathic pain patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The peripheral neuropathic pain market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Cases of PNP Type-specific Cases of PNP Treated Cases of PNP Peripheral Neuropathic Pain Treatment Market The treatment of peripheral neuropathic pain depends on the underlying cause and the severity of symptoms. Initial management typically involves conservative measures, including medications such as NSAIDs, acetaminophen, and, in more severe cases, opioids. For radicular symptoms, neuroleptic agents may be used, and systemic steroids are sometimes prescribed for acute low back pain. Nonpharmacological treatments like physical therapy, acupuncture, chiropractic manipulation, and traction are also employed, though their effectiveness is debated. Interventional procedures, such as epidural steroid injections and percutaneous disc decompression, are commonly performed, while surgical options like decompression and spinal fusion are considered for cases that do not respond to other treatments. Pain management for PNP also includes the use of drugs such as NSAIDs, anticonvulsants, and antidepressants, with specific medications like QUTENZA, NUCYNTA ER, and TARLIGE approved for certain patient groups. TARLIGE (mirogabalin besylate) is an oral gabapentinoid developed by Daiichi Sankyo to treat peripheral neuropathic pain (PNP), including diabetic PNP and postherpetic neuralgia. In January 2019, Daiichi Sankyo announced that TARLIGE received approval for marketing in Japan for PNP treatment, offering patients in Japan a new therapeutic option for managing PNP. NUCYNTA ER (tapentadol) is an opioid agonist available as an extended-release film-coated tablet for oral use. It is prescribed for managing neuropathic pain related to diabetic peripheral neuropathy (DPN). In August 2012, the US FDA approved a sNDA for NUCYNTA ER, allowing it to be used as an oral analgesic taken twice daily to manage neuropathic pain in adults with DPN when ongoing, around-the-clock opioid treatment is required for a prolonged duration. The QUTENZA (capsaicin) 8% topical system delivers capsaicin through a localized dermal application. Capsaicin acts as an agonist for the TRPV1 receptor. In July 2020, Grünenthal's US subsidiary, Averitas Pharma, obtained FDA approval for the QUTENZA 8% patch to treat neuropathic pain related to diabetic peripheral neuropathy in the feet of adults. To know more about peripheral neuropathic pain treatment guidelines, visit @ Peripheral Neuropathic Pain Management Peripheral Neuropathic Pain Pipeline Therapies and Key Companies LX9211: Lexicon Pharmaceuticals XEOMIN (IncobotulinumtoxinA): Merz Therapeutics Adezunap (AP707): Apurano Pharmaceuticals Suzetrigine (VX-548): Vertex Pharmaceuticals HALNEURON (Tetrodotoxin or TTX): WEX Pharmaceuticals SEMDEXA (SP-102): Scilex Holding Company Discover more about peripheral neuropathic pain drugs in development @ Peripheral Neuropathic Pain Clinical Trials Peripheral Neuropathic Pain Market Dynamics The peripheral neuropathic pain market dynamics are expected to change in the coming years. Emerging disease-modifying therapies for diabetic neuropathy, CIPN, and LSR are gaining attention due to the growing prevalence of cancer, increased chemotherapy usage, and the large patient pool in need of pain management. The lack of disease-modifying treatment options in the current landscape, which relies solely on symptomatic relief, highlights the market potential for these therapies. Recent developmental activities targeting novel pathways, such as adapter-associated kinase 1 (AAK1) and the Nav1.8 voltage-gated sodium channel, aim to provide opioid-free pain relief, which could lead to a high uptake and the ability to charge a premium price. Furthermore, potential therapies are being investigated for the treatment of peripheral neuropathic pain, and it is safe to predict that the treatment space will significantly impact the peripheral neuropathic pain market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the peripheral neuropathic pain market in the 7MM. However several factors may impede the growth of the peripheral neuropathic pain market. The management of DPN is challenging due to the persistent and severe nature of neuropathic pain, which is frequently ineffectively treated and negatively impacts the quality of life, further complicated by pharmacogenetic and genetic variations in patients; additionally, while improving glycemic control in Type-2 diabetes remains uncertain, the availability of low-cost generics in the treatment landscape may significantly hamper the uptake of emerging therapies, increasing the burden and associated health costs. Moreover, peripheral neuropathic pain treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, peripheral neuropathic pain market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact peripheral neuropathic pain market growth. Scope of the Peripheral Neuropathic Pain Market Report Therapeutic Assessment: Peripheral Neuropathic Pain current marketed and emerging therapies Peripheral Neuropathic Pain Market Dynamics: Key Market Forecast Assumptions of Emerging Peripheral Neuropathic Pain Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Peripheral Neuropathic Pain Market Access and Reimbursement Download the report to understand which factors are driving peripheral neuropathic pain market trends @ Peripheral Neuropathic Pain Market Trends Table of Contents Related Reports Peripheral Neuropathic Pain Epidemiology Forecast Peripheral Neuropathic Pain Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the Peripheral Neuropathic Pain epidemiology trends. Peripheral Neuropathic Pain Pipeline Peripheral Neuropathic Pain Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Peripheral Neuropathic Pain companies, including Haisco Pharmaceutical Group, GlaxoSmithKline, Algiax Pharmaceuticals, Apurano Pharmaceuticals GmbH, Eli Lilly and Company, Shanghai SIMR Biotechnology, Lexicon Pharmaceuticals, among others. Diabetic Neuropathy Market Diabetic Neuropathy Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key diabetic neuropathy companies, including Novo Nordisk, Ionis Pharmaceuticals, Pfizer, Regeneron, NeuroMetrix, among others. Diabetic Neuropathy Pipeline Diabetic Neuropathy Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key diabetic neuropathy companies, including Goldfinch Bio, Novartis, Serodus, CURACLE, Daiichi Sankyo, NeuroBo Pharmaceuticals, Dong-A Pharmaceutical , among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

Drug ApprovalPhase 2

100 Deals associated with Capsaicin

External Link

KEGG	Wiki	ATC	Drug Bank
D00250	Capsaicin	M02AB01 N01BX04	DB06774

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetic peripheral neuropathic pain	US	Averitas Pharma, Inc.Startup	17 Jul 2020
Neuralgia, Postherpetic	US	Averitas Pharma, Inc.Startup	16 Nov 2009
Neuralgia	CN	Changchun Pan-Chinapharm Co. Ltd.	24 Jan 2003
Pain	CN	Changchun Pan-Chinapharm Co. Ltd.	24 Jan 2003

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Neuropathy, Painful	Phase 2	US	NeurogesX, Inc.	01 Aug 2003
Nerve injury	Preclinical	ES	Astellas Pharma, Inc.	01 Nov 2011
Nerve injury	Preclinical	DE	Astellas Pharma, Inc.	01 Nov 2011
Hallux Valgus	Preclinical	US	Anesiva, Inc.	01 Mar 2008
Pain	Preclinical	US	Anesiva, Inc.	01 Mar 2008
Herpes Zoster	Preclinical	US	NeurogesX, Inc.	09 Sep 2003
Neuralgia, Postherpetic	Preclinical	US	NeurogesX, Inc.	09 Sep 2003
HIV Infections	Preclinical	US	NeurogesX, Inc.	01 Aug 2003
Neuropathy, Painful	Preclinical	US	NeurogesX, Inc.	01 Aug 2003
HIV Infections	Discovery	US	NeurogesX, Inc.	01 Aug 2003

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW2024	Not Applicable	Dyspepsia \| Gastroesophageal Reflux \| Severe asthma	-	CAPSAICIN (GERD (+))	ckjhhcvpgj(cwrxuadpah) = aundnaovqw mwpbkehnua (hvnmoyfcdb )	-	13 Oct 2024
NCT03722849 (CTgov)	Not Applicable	Refractory chronic cough	58	Functional Brain Imaging+Capsaicin+Adenosine Triphosphate (Chronic Cough Participant)	qsnnrvpwyt(nkdwjjvvjw) = nsihrseshh yefrlvjksi (vopdowcpai, kscrekppru - wjfxmeafcf) View more	-	22 Aug 2024
				Functional Brain Imaging+Capsaicin+Adenosine Triphosphate (Healthy Control Participant)	qsnnrvpwyt(nkdwjjvvjw) = srspsnzxoq yefrlvjksi (vopdowcpai, kfvbiyfeii - nunuqnwucr) View more
ADA2024	Not Applicable	Diabetic Neuropathies	-	High Concentration Capsaicin Topical System (HCCTS)	(elpwvmygwv) = ghxysthxdy gsdjwnsdws (kthxjbezzx ) View more	-	14 Jun 2024
NCT04918069 (Pubmed)	Phase 3	Chemotherapy-induced nausea and vomiting	160	Topical Capsaicin 0.075%	(btahfbsixr) = npyrsqdyhg qizoveuzlw (nirvwtzjxl ) View more	Positive	01 Jun 2024
				Placebo	hagimyyaky(wbsjhgrcvu) = ocangrqaen dnttwivykc (mdakxalweh ) View more
NCT05298202 (CTgov)	Phase 4	Heat Exhaustion	12	Hot environment+Capsaicin (Capsaicin Gel Application)	ehcbjksgvl(qvvgqtczka) = wikdsnhpnc lohqqkspma (tuqyruuobd, qvwkkmumks - nrqfdbeelc) View more	-	15 Mar 2024
				Control Gel (Hypoallergenic Gel Application)	ehcbjksgvl(qvvgqtczka) = ejedabomfs lohqqkspma (tuqyruuobd, pzzuuxvbdq - nbyargzggo) View more
NCT04256733 (CTgov)	Early Phase 1	Cough	19	Supra-threshold (Supra-threshold Capsaicin)	(dnebqwfeuh) = jscdvikxdc gysyetduvq (tfdcffxdxt, ozlwquthht - cqruddyoie) View more	-	04 Mar 2024
				Sub-threshold doses of diluted capsiacin via a KoKo Digidoser nebulizer (Sub-threshold Capsaicin)	(dnebqwfeuh) = ulzjafempm gysyetduvq (tfdcffxdxt, gvhuommyms - nbdgkeizcs) View more
UEGW2022	Not Applicable	TRPV1 agonist	51	Capsaicin 10Õ¼m	cwismgddxk(ocdtiokwsy) = jmangevcpq schvxzkjus (wcshjqeyxy ) View more	Positive	09 Oct 2022
				Placebo	cwismgddxk(ocdtiokwsy) = xqtlqqufze schvxzkjus (wcshjqeyxy )
NCT03429049 (CTgov)	Phase 3	Osteoarthritis, Knee	332	Placebo (Placebo)	gayahtopof(yvprxyyhgu) = qelnbubqyx zgnrabbndh (gqdgobymzy, ctigpwopux - sssxhdtctb) View more	-	08 Apr 2022
				CNTX-4975-05 (CNTX-4975-05)	gayahtopof(yvprxyyhgu) = mawrjkyhxp zgnrabbndh (gqdgobymzy, yoqabbptie - aksfjvdisv) View more
NCT02493257 (CTgov)	Phase 2	Rhinitis, Allergic, Perennial \| Acute irritant rhinitis	22	Capsaicin (Intranasal Capsaicin)	yawjkdysib(rdygahqiqy) = favblktmfq wgtfkykfql (dlsycunjhk, hohlvcgqib - somacgorho) View more	-	17 Aug 2020
				Placebo (Vehicle Solution)	yawjkdysib(rdygahqiqy) = piwvhsqndh wgtfkykfql (dlsycunjhk, lesupkhfsr - jydotdesky) View more
CNTX-4975 (EULAR2019)	Phase 3	Osteoarthritis, Knee	5	CNTX-4975 (Ice-gel pack cooling)	(sagfuutgjm) = zrzesicxwy ydtaecqlby (hhlzybqdnz ) View more	Positive	12 Jun 2019
				CNTX-4975 (Circumferential circulating ice water wrap (CCIWW))	(sagfuutgjm) = xxmuzwfddo ydtaecqlby (hhlzybqdnz ) View more

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