// Pipeline data for VivaMed BioPharma. // // 17 active drug candidates across 5 therapeutic areas, copied verbatim // from druginfo.md (the approved internal source-of-truth). Per the // "word for word" requirement, the short and long fields are preserved // byte-for-byte from the source — including any typos, double spaces, // curly apostrophes, and non-breaking hyphens. window.TA_PORTFOLIO = [ { key: "neurology", name: "Neurology", dot: "#004AAD", desc: "Neurodegeneration, autoimmune neurology, and rare CNS disorders — mechanistically stratified at entry.", }, { key: "pain", name: "Pain Management", dot: "#306CBC", desc: "Non-opioid analgesics and repurposed compounds for chronic and neuropathic pain phenotypes.", }, { key: "psychiatry", name: "Psychiatry", dot: "#145CDB", desc: "Treatment-resistant depression, mood disorders, and novel receptor-class therapeutics.", }, { key: "pulmonology", name: "Pulmonology", dot: "#3393F0", desc: "Severe asthma, COPD subtypes, and idiopathic pulmonary fibrosis — biomarker-stratified trials.", }, { key: "rheumatology", name: "Rheumatology", dot: "#0A2B5C", desc: "Autoimmune and mast-cell disorders; rare connective-tissue diseases with unmet need.", }, ]; // Top-line rollup shown in the pipeline hero. window.PORTFOLIO_TOTALS = { assetsLabel: "50+", licensedLabel: "150+", approvalsLabel: "39", ta: 5, }; // Map a free-text "next phase" blurb to a stage bucket used by the Gantt. window.stageOf = function(nextPhase){ const s = (nextPhase || "").toLowerCase(); if (s.includes("phase 3") || s.includes("pivotal phase 3")) return "Phase 3"; if (s.includes("phase 2") || s.includes("phase iia") || s.includes("phase 2a")) return "Phase 2"; if (s.includes("phase 1")) return "Phase 1"; if (s.includes("ind") || s.includes("glp") || s.includes("preclinical") || s.includes("nonclinical")) return "Preclinical"; return "Discovery"; }; window.PIPELINE_STAGES = ["Discovery", "Preclinical", "Phase 1", "Phase 2", "Phase 3"]; window.PIPELINE_ASSETS = [ { code: "VM-NEU-001", ta: ["neurology"], disease: "Parkinson’s Disease", drugType: "Neurosteroid", classification: "First-in-class", nextPhase: "Phase 1 clinical trial in Parkinson’s Disease to establish safety, tolerability, PK, and early biomarker signals.", short: "A regenerative therapeutic candidate in development for neurodegenerative diseases, beginning with Parkinson’s disease.", long: [ "A first-in-class regenerative therapeutic for neurodegenerative diseases, with a primary focus on Parkinson’s Disease (PD) and a secondary focus on Alzheimer’s Disease (AD). This program is built on a robust scientific foundation with a mechanism designed to restore homeostatic GABAergic tone, which is critically depleted in chronic stress and neurodegeneration. Beyond symptomatic relief, compelling preclinical and clinical evidence suggests this candidate has disease-modifying and regenerative potential. This treatment is associated with a slowed rate of hippocampal atrophy, with a subset of patients, particularly APOE ε4 carriers. These results provide the first human evidence of a potential regenerative effect, validating the mechanism and significantly de-risking the development path.", ], }, { code: "VM-NEU-002", ta: ["neurology"], disease: "Alzheimer's Disease", drugType: "Small molecule", classification: "First-in-class", nextPhase: "IND-enabling.", short: "A novel CNS therapeutic candidate being developed for early Alzheimer’s disease.", long: [ "A potential first-in-class, disease-modifying therapy for Mild Cognitive Impairment (MCI) and early Alzheimer’s Disease (AD), mechanism to restore brain positions as a differentiated therapy in a landscape dominated by amyloid-targeting drugs, addressing the fundamental neurodegenerative processes of AD. The asset is currently in nonclinical development, with plans to the final IND-enabling studies, GMP manufacturing, and readiness for first-in-human trials.", ], }, { code: "VM-NEU-003", ta: ["neurology"], disease: "Focal Epilepsy - DEE", drugType: "Small molecule", classification: "First-in-class", nextPhase: "Complete GLP toxicology and advance into IND-enabling studies.", short: "A selective CNS therapy under development for individuals with treatment-resistant epilepsies.", long: [ "A first-in-class, allosteric, and highly selective for the treatment of refractory epilepsy, advancing through critical IND-enabling studies and Phase 1/2 clinical trials. Approximately 30% of epilepsy patients are refractory to current treatments, and over half reporting debilitating side effects. Our candidate is uniquely positioned to address this gap by offering a trifecta of potential therapeutic benefits: seizure control, pro-cognitive effects, and a psychiatric-neutral profile. Preclinical data is extensive and compelling, demonstrating broad-spectrum anti-seizure efficacy across multiple models. The asset has promising pharmacokinetics, CNS penetration, and a strategic plan designed to achieve key value-inflection milestones.", ], }, { code: "VM-PAIN-001", ta: ["pain"], disease: "CRPS", drugType: "Modified-release small molecule formulation", classification: "First-in-class", nextPhase: "Phase 2 CRPS study; possible postoperative pain arm.", short: "An oral extended-release formulation being developed for individuals living with severe chronic pain.", long: [ "A first-in-class, oral prolonged-release (PR) ketamine tablet for the treatment of refractory chronic pain, beginning with the orphan indication of Complex Regional Pain Syndrome (CRPS). Our therapeutic strategy is built on a novel approach that leverages a proprietary formulation to maximize the generation of therapeutic metabolites while minimizing the psychoactive and cardiovascular side effects that have long hindered ketamine’s potential as a chronic oral therapy. The program is supported by a robust Phase 1 clinical data package demonstrating an excellent safety profile that validates our mechanism, and is poised to enter a Phase 2 clinical trial CRPS designed to demonstrate clinical proof-of-concept.", ], }, { code: "VM-PAIN-002", ta: ["pain"], disease: "Post Op. Pain", drugType: "Small molecule", classification: "First-in-class", nextPhase: "IND-enabling studies.", short: "An investigational therapy aimed at improving pain control following surgical procedures.", long: [ "A first-in-class kappa opioid receptor (KOR) positioned to fundamentally disrupt the $25 billion post-operative pain market by offering potent analgesia without the abuse potential, respiratory depression, and severe side effects that plague current standard-of-care opioids. The opioid crisis has created a profound and urgent unmet need for effective, non-addictive pain therapeutics. While the KOR has long been a promising target for non-addictive analgesia, previous development attempts have failed due to debilitating side effects like dysphoria and sedation. This program’s innovative mechanism is designed to overcome this historical barrier and has demonstrated a compelling and differentiated profile in robust preclinical models, including non-human primates. The program is currently in the nonclinical phase, with plans of completing all IND-enabling studies by January 2027.", ], }, { code: "VM-PAIN-003", ta: ["neurology", "pain"], isLead: true, disease: "Trigeminal Neuralgia", drugType: "Small molecule", classification: "First-in-class", nextPhase: "Complete IND-enabling Phase 1 safety study in healthy volunteers.", short: "A novel small-molecule program being developed for severe neuropathic pain, including trigeminal neuralgia.", long: [ "A novel, first-in-class small molecule therapeutic for the treatment of severe neuropathic pain. This asset represents a paradigm shift in pain management by targeting the genetically validated, yet historically undruggable, channels through a novel, indirect mechanism. This approach has demonstrated profound and durable analgesic effects in extensive preclinical models without the addiction liability, tolerance, or side effects that plague current standards of care, including opioids and gabapentinoids.", "This asset is currently in the final stage of preclinical development, including all IND-enabling studies and GMP manufacturing. The primary indication will be Trigeminal Neuralgia, an orphan disease characterized by excruciating facial pain, with a clear path to expand into the broader neuropathic pain market. The asset is supported by a robust intellectual property portfolio, a Cooperative Research and Development Agreement (CRADA) with the NIH National Center for Advancing Translational Sciences (NCATS) as part of the HEAL Initiative, and a compelling preclinical data package demonstrating a high probability of technical and regulatory success.", ], }, { code: "VM-PAIN-004", ta: ["neurology", "pain"], disease: "Neuropathic Pain and CRPS", drugType: "Small molecule", classification: "First-in-class", nextPhase: "Pivotal Phase 3 trial in CRPS.", short: "An oral repurposed therapeutic in late-stage development for complex regional pain syndrome.", long: [ "A first-in-class oral therapeutic for neuropathic pain (NP) with complex regional pain syndrome (CRPS) as the first indication and a perfect steppingstone for introducing this candidate into the field of chronic NP.", "For decades, CRPS has remained without a single FDA or EMA-approved treatment, creating a profound and desperate unmet medical need. Our program represents the only scientifically robust and clinically efficacious late-stage effort poised to become the definitive 1st‑line standard of care for this devastating orphan disease.", "This program is a novel repurposed formulation that has been marketed globally for treatment of lung cancer for over a decade. Our strategy enables a highly efficient and de‑risked development path by leveraging the existing pre‑clinical and safety data. We have Orphan Drug Designation in both the US and EU, providing powerful regulatory and commercial advantages.", "We have secured a comprehensive data package from the originator including full preclinical and Phase 1 safety data, which significantly de‑risks the development path allowing us to proceed directly to a single pivotal trial.", ], }, { code: "VM-PSY-001", ta: ["psychiatry"], disease: "Alcohol Use Disorder", drugType: "Small molecule", classification: "Best-in-class", nextPhase: "Phase 2a proof-of-concept study in AUD.", short: "An investigational oral therapy being developed for individuals with alcohol use disorder.", long: [ "A potential best-in-class, bioavailable, oral therapeutic for the treatment of Alcohol Use Disorder (AUD). AUD is a significant public health crisis with a profound unmet need for safer, more effective therapies. When tested against current treatments, our candidate was found to be considerably more effective. Its mechanism has strong clinical validation, with preclinical data demonstrating a significantly improved safety profile alongside robust, dose-dependent efficacy in validated animal models of alcohol consumption. When tested for toxicological effects, it was found to be without any toxicity in rats and dogs. An IND for this candidate was to the FDA in Q4 2025.", ], }, { code: "VM-PSY-002", ta: ["psychiatry"], disease: "Stimulant Use Disorder", drugType: "Small-molecule combination", classification: "Repurposed dual-mechanism therapy", nextPhase: "Phase 2 program initiation.", short: "A fixed-dose combination being evaluated as a potential treatment option for individuals with cocaine use disorder.", long: [ "A fixed-dose combination for the treatment of Cocaine Use Disorder (CUD), with a strategic focus on patients with co-morbid Post-Traumatic Stress Disorder (PTSD). For nearly four decades, the medical community has searched for an effective pharmacotherapy for CUD without success, leaving a significant and desperate unmet medical need. Our program represents the first scientifically robust, late-stage clinical effort poised to break this impasse.", "This asset is a repurposed combination of two well-characterized drugs, enabling an efficient regulatory pathway and leveraging a designation as a Breakthrough Therapy. Strong human proof-of-concept has already been established in a placebo-controlled clinical study, and we are currently initiating a Phase 2 program.", ], }, { code: "VM-PSY-003", ta: ["psychiatry"], disease: "Opioid Use Disorder", drugType: "Repurposed small molecule combination", classification: "First-in-class repurposed therapy", nextPhase: "Phase 2 (pivotal)", short: "A combination therapy in development to support patients seeking treatment for opioid use disorder.", long: [ "A first-in-class, repurposed small molecule combination therapy for the treatment of Opioid Use Disorder (OUD) designed to address the profound unmet needs of the current OUD crisis. This candidate offers a differentiated approach to current standards of care by targeting novel neurobiological pathways, moving beyond simple opioid receptor agonism/antagonism. The program is advancing to a pivotal Phase 2 clinical trial, supported by a robust preclinical package and a successful Phase 1 study", ], }, { code: "VM-PSY-004", ta: ["psychiatry"], disease: "Tobacco Use Disorder", drugType: "Small molecule", classification: "Best-in-class", nextPhase: "Phase 2a", short: "A next-generation small molecule in development for adults trying to reduce or stop tobacco use.", long: [ "A novel, best-in-class small molecule program for the treatment of Tobacco Use Disorder. The limitations of current standards-of-care, such as varenicline (Chantix), are well-documented, including neuropsychiatric side effects and modest long-term efficacy, which stem from non-selective receptor activity. Our program represents a new generation of nicotine derivatives engineered for subtype selectivity. This approach aims to uncouple the therapeutic benefit from the negative side effect profile of existing treatments. The program is currently at the Nonclinical Phase 2 stage with a planned Phase IIa proof-of-concept study, which would provide a robust data package demonstrating clinical efficacy and a superior safety profile.", ], }, { code: "VM-PSY-005", ta: ["psychiatry"], disease: "Opioid Use Disorder", drugType: "Small molecule", classification: "First-in-class", nextPhase: "IND planned", short: "An oral small-molecule candidate in development for opioid use disorder.", long: [ "A first-in-class, orally administered modulator engineered with a unique mechanism that represents a paradigm shift in OUD treatment. Preclinical data demonstrate a highly differentiated Target Product Profile, with no abuse potential, minimal withdrawal, and exceptional oral bioavailability.", "The program is at the Nonclinical Phase 2 (IND-enabling) stage with strategic plans to complete all necessary IND-enabling activities, including GMP manufacturing and GLP toxicology, and file an Investigational New Drug (IND) application with the FDA.", ], }, { code: "VM-PSY-006", ta: ["psychiatry"], disease: "Post Traumatic Stress", drugType: "Small molecule", classification: "First-in-class", nextPhase: "IND submission and Phase 1 human trial in PTSD", short: "A cannabinoid-based investigational therapy being developed for post-traumatic stress disorder.", long: [ "A novel, first-in-class Cannabinoid Receptor for the treatment of Post-Traumatic Stress Disorder (PTSD). This asset represents a paradigm shift in CNS therapeutics, leveraging decades of world-leading research in endocannabinoid chemistry to address a significant unmet medical need. The program is currently in the Nonclinical Phase 2 stage of development, with a clear path toward completion of IND-enabling toxicology, CMC activities, file an Investigational New Drug (IND) application with the FDA, and initiate a Phase 1 clinical study.", ], }, { code: "VM-PUL-001", ta: ["pulmonology"], disease: "Acute Respiratory Distress Synd.", drugType: "Monoclonal antibody", classification: "First-in-class", nextPhase: "Phase 2b", short: "A first-in-class monoclonal antibody in Phase 2 development for Acute Respiratory Distress Syndrome, aiming to address a critical unmet need in a condition with no approved therapies.", long: [ "A first-in-class, Phase 2 novel and critical driver of advancing science in treating the condition of Acute Respiratory Distress Syndrome (ARDS), with a mortality rate reaching upwards of 40%, and without approved therapeutics. This program has the potential to fundamentally change the treatment paradigm for a condition with staggering unmet medical need and mortality. The primary molecule initiates and perpetuates the uncontrolled inflammation and vascular lung injury characteristic of ARDS and is validated by robust preclinical data across multiple relevant small and large animal models and supported by human translational studies. The program has successfully completed a 32-subject Phase 1a study in healthy volunteers, demonstrating an excellent safety and tolerability profile with zero serious adverse events. The program has also been evaluated in a Phase 2a study in moderate/severe ARDS patients. Initial data from the first patient cohort of 15 patients is highly encouraging, showing the absence of serious drug-related adverse events and a pharmacokinetic profile consistent with Phase 1 results. With a breakthrough therapy designation, a validated target, a clear biomarker strategy, and a de-risked clinical profile, this candidate represents a compelling, high-impact investment opportunity in a major market with no effective pharmacological treatments.", ], }, { code: "VM-RHE-001", ta: ["rheumatology"], disease: "Gout", drugType: "Biologic", classification: "First-in-class", nextPhase: "Phase 2a POC study assessing tophus reduction and inflammatory biomarkers.", short: "A localized treatment being developed to address unmet needs in patients with gout.", long: [ "A next-in-class repurposed therapy for gout and similar inflammatory pain conditions, this candidate’s foundational technology features pairs of cationic and anionic peptides that co-assemble to form fibrillar structures. By varying peptide type, peptide concentration, or vehicle fabrication conditions, VivaMed can create nano-, micro-, or macro-scale vehicles to facilitate efficient delivery of anti-inflammatory APIs.", ], }, { code: "VM-RHE-002", ta: ["rheumatology"], disease: "Osteoarthritis CKD", drugType: "Small molecule", classification: "First-in-class", nextPhase: "Phase 2a Proof-of-Concept in Osteoarthritis (OA).", short: "An oral therapy in development for chronic pain associated with osteoarthritis in patients with limited treatment options.", long: [ "A potent, first-in-class, oral agent for treatingOsteoarthritis (OA), including those with chronic kidney disease (CKD). This candidate avoids the gastrointestinal (GI), cardiovascular, and renal toxicities of NSAIDs. A high-value secondary indication is Traumatic Brain Injury (TBI), which is strongly supported by extensive research validating sEH as a critical therapeutic target for reducing neuroinflammation and promoting neurological recovery. Successful completion of three Phase 1 trials in healthy volunteers, demonstrating a clean safety and tolerability profile at doses that inhibit sEH activity with improved pharmaceutical properties, strong PK/PD correlation, limited food and drug-drug interactions, and a validated pharmacodynamic biomarker that de-risks future clinical studies.", ], }, { code: "VM-RHE-003", ta: ["rheumatology"], disease: "Fibromyalgia", drugType: "Small molecule", classification: "First-in-class", nextPhase: "Phase 2 Proof-of-Concept in Fibromyalgia", short: "A repurposed oral therapy being developed for chronic pain conditions such as fibromyalgia.", long: [ "A de-risked, first-in-class therapeutic to meet the need for a new generation of safe, effective, and non-addictive pain treatment. This agent is a repurposed FDA-approved drug for the treatment of chronic pain, with a lead indication in Fibromyalgia. Its novel mechanism of action (MoA) is supported by robust preclinical data and a meta-analysis of over 12,000 patients from prior clinical trials demonstrating a statistically significant analgesic effect.", ], }, ];