Fibromyalgia - Pipeline Insight, 2025

This “Fibromyalgia - Pipeline Insight, 2025” report provides comprehensive insights about 8+ companies and 10+ pipeline drugs in Fibromyalgia pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Fibromyalgia: Understanding

Fibromyalgia: Overview

Fibromyalgia Syndrome (FMS) is a chronic condition characterized by widespread musculoskeletal pain, often accompanied by fatigue, sleep disturbances, cognitive dysfunction (fibro fog), and mood disorders such as anxiety and depression. Although the exact cause remains unclear, FMS is thought to result from a combination of genetic, neurobiological, and environmental factors that lead to alterations in pain processing and central sensitization, where the nervous system becomes hypersensitive to pain signals. Affecting approximately 6% to 15% of the population, with a notably higher prevalence in women, fibromyalgia significantly impacts daily life, making routine activities challenging and often leading to impaired physical, emotional, and social functioning.

The etiology of fibromyalgia is complex and multifactorial, involving an interplay of genetic, neurobiological, psychological, and environmental factors. Central sensitization is widely regarded as a key mechanism in the development of fibromyalgia, where alterations in pain processing pathways within the central nervous system lead to an exaggerated response to pain stimuli. This heightened pain sensitivity, often referred to as 'amplified pain perception,' is thought to result from dysregulation of various neurotransmitters, including serotonin, norepinephrine, and substance P, which are crucial in modulating pain and mood. Furthermore, research suggests that a genetic predisposition may increase susceptibility to fibromyalgia, with certain genetic markers linked to its development. Hormonal factors, particularly imbalances in estrogen and cortisol, may also play a role, as they influence pain perception and the body’s response to stress. Psychological stressors, including past trauma, emotional distress, and chronic stress, are also commonly reported triggers or exacerbating factors for fibromyalgia symptoms, with studies showing a strong connection between trauma (such as physical or emotional abuse) and the onset of the syndrome.

The clinical presentation of fibromyalgia is characterized by chronic, widespread musculoskeletal pain that often fluctuates in intensity, with periods of exacerbation and relief. Patients typically report pain that is bilateral, affecting both the upper and lower parts of the body, with common areas of involvement including the neck, shoulders, back, and hips. The pain is often described as a deep, aching sensation, which can vary in severity from mild to disabling. In addition to persistent pain, individuals with fibromyalgia frequently experience significant fatigue that is not alleviated by rest, along with unrefreshing sleep, which further exacerbates daytime tiredness and cognitive difficulties. These cognitive issues, often referred to as 'fibro fog,' involve problems with attention, memory, concentration, and mental clarity, severely impacting work and daily activities. Other common symptoms include stiffness, particularly in the morning or after periods of inactivity, and mood disturbances such as anxiety and depression, which are frequently seen in fibromyalgia patients due to the chronic nature of the condition. Many also experience a range of somatic complaints, such as headaches, irritable bowel syndrome (IBS), and other gastrointestinal issues, contributing to the overall burden of the condition.

The treatment of fibromyalgia focuses on alleviating symptoms and improving quality of life through a multimodal approach that combines pharmacological and non-pharmacological strategies. Regular exercise is a key component, with low-impact aerobic exercises such as walking, swimming, and cycling shown to reduce pain and improve overall function. Cognitive Behavioral Therapy (CBT) and other forms of psychological therapy are also effective, helping patients develop coping mechanisms to manage chronic pain and address the emotional aspects of the condition. On the pharmacological side, medications that target pain, improve sleep, and reduce muscle stiffness are commonly used. Additionally, tricyclic antidepressants and muscle relaxants may be prescribed to help manage specific symptoms. Because fibromyalgia varies greatly from patient to patient, treatment plans often require adjustments and a combination of therapies to achieve optimal results. With proper management, many individuals with fibromyalgia can experience symptom reduction and improvements in daily functioning and overall quality of life.

'Fibromyalgia- Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Fibromyalgia pipeline landscape is provided which includes the disease overview and Fibromyalgia treatment guidelines. The assessment part of the report embraces, in depth Fibromyalgia commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Fibromyalgia collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Fibromyalgia R&D. The therapies under development are focused on novel approaches to treat/improve Fibromyalgia.

Fibromyalgia Emerging Drugs Chapters

This segment of the Fibromyalgia report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Fibromyalgia Emerging Drugs

TNX-102 SL: Tonix Pharmaceuticals, Inc.

TNX-102 SL is a small, rapidly-disintegrating, under the tongue (sublingual) product candidate containing 2.8 mg of cyclobenzaprine HCl. The unique patented formulation has been designed to optimize the delivery and absorption of cyclobenzaprine for the therapeutic benefit of improving sleep quality, while minimizing the potential residual effects of oral formulations of cyclobenzaprine. TNX-102 SL is a centrally acting analgesic that helps in relieving pain by improving sleep. As a multifunctional agent with potent binding and antagonist activities at the serotonin2A, α1-adrenergic, histaminergic-H1, and muscarinic-M1 receptors, TNX-102 SL is in clinical development and has active IND’s as a daily bedtime treatment for fibromyalgia. Currently, the drug is in Preregistration stage of its clinical trial for the treatment of Fibromyalgia.

Rozanolixizumab: UCB Biopharma SRL

Rozanolixizumab is an investigational humanized monoclonal antibody that specifically binds to human neonatal Fc receptor (FcRn). It has been designed to block the interaction of FcRn and IgG, inhibiting IgG recycling and inducing the removal of pathogenic IgG autoantibodies. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Fibromyalgia.

IMC-1: Dogwood Therapeutics

IMC-1 is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress herpes virus replication, with the end goal of reducing virally promoted disease symptoms. IMC-1, combines 2 specific mechanisms of action purposely designed to inhibit HSV-1 activation and replication, thereby keeping HSV-1 in a latent (dormant) state or down-regulating HSV-1 from a lytic (active) state back to latency. The famciclovir component of IMC-1 inhibits viral DNA replication and thus inhibits upregulation of the HSV-1 virus. The celecoxib component of IMC-1 inhibits cyclooxegenase-2 (COX-2) and to a lesser degree COX-1, enzymes used by HSV-1 to amplify or accelerate its own replication. Currently, the drug is in the Phase II stage of development to treat Fibromyalgia.

Fibromyalgia: Therapeutic Assessment

This segment of the report provides insights about the different Fibromyalgia drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Fibromyalgia

• There are approx. 8+ key companies which are developing the therapies for Fibromyalgia. The companies which have their Fibromyalgia drug candidates in the most advanced stage, i.e. Preregistration include, Tonix Pharmaceuticals, Inc.

Phases

The report covers around 10+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Fibromyalgia pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Fibromyalgia: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Fibromyalgia therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Fibromyalgia drugs.

Fibromyalgia Report Insights

• Fibromyalgia Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Fibromyalgia Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Fibromyalgia drugs?
• How many Fibromyalgia drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Fibromyalgia?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Fibromyalgia therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Fibromyalgia and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• UCB Biopharma SRL
• Tonix Pharmaceuticals, Inc.

Dogwood Therapeutics

• Silo Pharma

Key Products

• Rozanolixizumab
• TNX-102 SL
• IMC-1
• Transdermal ketamine

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