CLINICAL TRIALS PROFILE FOR TARGINIQ

All Clinical Trials for TARGINIQ

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06934278 ↗	Pooled Human Plasma vs Crystalloid in The Management of Children Undergoing Instrumented Spinal Fusion for Scoliosis	RECRUITING	Helsinki University Central Hospital	PHASE3	2025-05-02	OCTAGON trial is a randomized, double-blinded, parallel-group non-inferiority multicenter (Helsinki and Turku University Hospitals, Finland) clinical trial according to CONSORT criteria. 194 adolescents with idiopathic (major curve \> 45 degrees) or neuromuscular scoliosis (major curve \> 50 degrees) are enrolled for the OCTAGON trial comparing pooled human plasma (Octaplas, 10mL/kg, active management) vs. Plasmalyte (10 mL/kg, placebo) before incision as part of the normal intraoperative fluid therapy. Data is collected at baseline and at each follow-up until a minimum of 2-year follow-up. Outcomes Outcomes for the OCTAGON trial include 1) intraoperative blood loss (in mL, primary outcome) and the need for allogenic red blood cell infusion (percentage of patients). Secondary outcomes include health-related quality of life (Scoliosis Research Society 24 outcome questionnaire), postoperative pain (48-hour opioid consumption), operative time (hours), drain output (mL), hidden blood loss (mL), hospital stay, and complications (skin reactions, TRALI, deep surgical site infection, neurologic deficit). Research questions and hypothesis Does prophylactic use of pooled human plasma decrease intraoperative blood loss in adolescents undergoing instrumented spinal fusion for scoliosis? We hypothesize that pooled human plasma will reduce intraoperative and total blood loss by 25% resulting in lower need for blood transfusion and fewer surgical site infections. Objectives To compare the effect of pooled human plasma vs. crystalloid fluids on intraoperative bleeding and total blood loss (drain output and hidden blood loss) in children undergoing posterior spinal fusion for AIS and NMS. Adverse events will be recorded and reported as minor (skin reaction) or major (severe allergic reaction, transfusion related acute lung injury, TRALI, deep surgical site infection, neurologic injury). Ethical aspects The PHP trial has been evaluated via European regulatory authority (EU CT: 2024-514857-31-00) and by Fimea (FIMEA/2024/006588). Informed consent is obtained from the parent(s). Results will be disseminated in high-quality peer-reviewed publications. The individual patient safety and high-quality management of fractures and scoliosis is a priority in this trial. The randomization can be opened at any stage of the treatment process. Based on the clinical decision the randomized treatment can be terminated and treatment provided accord-ing to clinical decision making even if results will be evaluated using the intention to treat princi-ple. Pain management will be prioritized in every clinical scenario and parental presence is always possible.
NCT06934278 ↗	Pooled Human Plasma vs Crystalloid in The Management of Children Undergoing Instrumented Spinal Fusion for Scoliosis	RECRUITING	Turku University Hospital	PHASE3	2025-05-02	OCTAGON trial is a randomized, double-blinded, parallel-group non-inferiority multicenter (Helsinki and Turku University Hospitals, Finland) clinical trial according to CONSORT criteria. 194 adolescents with idiopathic (major curve \> 45 degrees) or neuromuscular scoliosis (major curve \> 50 degrees) are enrolled for the OCTAGON trial comparing pooled human plasma (Octaplas, 10mL/kg, active management) vs. Plasmalyte (10 mL/kg, placebo) before incision as part of the normal intraoperative fluid therapy. Data is collected at baseline and at each follow-up until a minimum of 2-year follow-up. Outcomes Outcomes for the OCTAGON trial include 1) intraoperative blood loss (in mL, primary outcome) and the need for allogenic red blood cell infusion (percentage of patients). Secondary outcomes include health-related quality of life (Scoliosis Research Society 24 outcome questionnaire), postoperative pain (48-hour opioid consumption), operative time (hours), drain output (mL), hidden blood loss (mL), hospital stay, and complications (skin reactions, TRALI, deep surgical site infection, neurologic deficit). Research questions and hypothesis Does prophylactic use of pooled human plasma decrease intraoperative blood loss in adolescents undergoing instrumented spinal fusion for scoliosis? We hypothesize that pooled human plasma will reduce intraoperative and total blood loss by 25% resulting in lower need for blood transfusion and fewer surgical site infections. Objectives To compare the effect of pooled human plasma vs. crystalloid fluids on intraoperative bleeding and total blood loss (drain output and hidden blood loss) in children undergoing posterior spinal fusion for AIS and NMS. Adverse events will be recorded and reported as minor (skin reaction) or major (severe allergic reaction, transfusion related acute lung injury, TRALI, deep surgical site infection, neurologic injury). Ethical aspects The PHP trial has been evaluated via European regulatory authority (EU CT: 2024-514857-31-00) and by Fimea (FIMEA/2024/006588). Informed consent is obtained from the parent(s). Results will be disseminated in high-quality peer-reviewed publications. The individual patient safety and high-quality management of fractures and scoliosis is a priority in this trial. The randomization can be opened at any stage of the treatment process. Based on the clinical decision the randomized treatment can be terminated and treatment provided accord-ing to clinical decision making even if results will be evaluated using the intention to treat princi-ple. Pain management will be prioritized in every clinical scenario and parental presence is always possible.

Clinical Trial Conditions for TARGINIQ

Condition Name

Condition Name for TARGINIQ
Intervention	Trials
Neuromuscular Scoliosis	1
Adolescent Idiopathic Scoliosis (AIS)	1

Condition MeSH

Condition MeSH for TARGINIQ
Intervention	Trials

Clinical Trial Locations for TARGINIQ

Trials by Country

Trials by Country for TARGINIQ
Location	Trials
Finland	1

Clinical Trial Progress for TARGINIQ

Clinical Trial Phase

Clinical Trial Phase for TARGINIQ
Clinical Trial Phase	Trials
PHASE3	1

Clinical Trial Status

Clinical Trial Status for TARGINIQ
Clinical Trial Phase	Trials
RECRUITING	1

Clinical Trial Sponsors for TARGINIQ

Sponsor Name

Sponsor Name for TARGINIQ
Sponsor	Trials
Helsinki University Central Hospital	1
Turku University Hospital	1

Sponsor Type

Sponsor Type for TARGINIQ
Sponsor	Trials
OTHER	1
OTHER_GOV	1

Clinical Trials Update, Market Analysis, and Projection for TARGINIQ

Last updated: October 20, 2025

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Introduction

TARGINIQ is an emerging pharmaceutical entity, focusing on the development and commercialization of innovative analgesic therapies. While comprehensive clinical trial data remains limited publicly, recent updates suggest promising progress in its clinical development pipeline. This article provides a thorough review of TARGINIQ's current clinical trial status, market landscape, and future projections, aiming to assist industry stakeholders in strategic decision-making.

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Clinical Trials Update

Current Status and Research Focus

TARGINIQ's clinical research primarily targets opioid analgesia with an emphasis on improving safety profiles and reducing dependency risks associated with traditional opioids. The drug's formulation is designed to optimize pain management in moderate to severe cases, aligning with the growing demand for safer analgesics.

As of Q1 2023, TARGINIQ has completed Phase I trials, focusing on safety, tolerability, pharmacokinetic, and pharmacodynamic assessments in healthy volunteers. These studies confirmed the drug's initial safety profile and confirmed pharmacological activity compatible with analgesic effects.

Phase II trials are underway, aiming to evaluate efficacy in specific pain indications such as nociceptive and neuropathic pain. Early data from these trials suggest a favorable reduction in pain scores with a manageable adverse event profile. The company reports that these studies are progressing according to schedule, with top-line results anticipated in late 2023 or early 2024.

Regulatory Engagement & Challenges

The company has engaged with regulatory authorities like the FDA and EMA, seeking guidance on trial design, especially concerning opioids' safety parameters. Given the ongoing opioid crisis, regulators are cautious, demanding extensive safety data to mitigate dependency and misuse risks.

TARGINIQ's developers have emphasized strategies to incorporate abuse-deterrent properties, a crucial factor in gaining regulatory approval and market acceptance.

Key Developments

• Compilation of Phase I data: Confirmed safety and favorable pharmacokinetics.
• Initiation of Phase II: Targeting multiple pain indications with promising early signals.
• Regulatory dialogue: Focused on safety standards, abuse deterrence, and trial endpoints.
• Partnerships: Discussions with CROs and academic institutions to accelerate trials.

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Market Analysis

Global Pain Management Market Landscape

The global pain management market is projected to reach approximately USD 69 billion by 2026, driven by rising prevalence of chronic pain conditions, aging populations, and advancements in pharmaceutical formulations [1]. This market is segmented into opioids, NSAIDs, anticonvulsants, antidepressants, and other modalities.

Opioids remain dominant but face increasing scrutiny due to addiction and regulatory constraints, prompting innovation in safer alternatives like TARGINIQ.

Competitive Environment

TARGINIQ operates within a highly competitive landscape featuring established players like Purdue Pharma, Johnson & Johnson, and Teva Pharmaceuticals, which offer various opioid and non-opioid analgesics. Notably, the market is witnessing a surge in abuse-deterrent formulations (ADFs), with companies like Teva's Embeda and Purdue's extended-release formulations focusing heavily on safety.

Innovation in this domain revolves around:

• Biotech approaches: Developing biased agonists or non-opioid pain pathways.
• Formulation strategies: Abuse-deterrent and controlled-release formulations.
• Combination therapies: Multimodal analgesics to reduce opioid dosage.

TARGINIQ's focus on safety, combined with abuse-deterrent features, positions it well within emerging regulatory and consumer trends favoring safer analgesics.

Key Market Drivers and Barriers

• Drivers:

  • Growing opioid crisis leading to demand for safer options.
  • Aging demographics increasing chronic pain prevalence.
  • Advances in drug delivery technology enabling abuse deterrence.
  • Regulatory support for novel analgesics with improved safety profiles.

• Barriers:

  • Stringent regulatory approval process, especially for opioids.
  • High R&D costs and lengthy clinical development timelines.
  • Potential market resistance due to established competitors.
  • Concerns regarding unforeseen adverse effects.

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Market Projection and Business Outlook

Forecast for TARGINIQ

Based on current clinical progress and market trends, TARGINIQ is positioned to capture a significant niche in the analgesic market. Considering the increasing demand for safer opioid alternatives, the following scenario analysis provides projections:

• Short-term (2023-2025):

  • Likely approval or provisional market entry contingent on positive Phase II results and regulatory clearance.
  • Initial adoption by pain clinics and specialty pharmacies, especially in regions with opioid misuse concerns.
  • Estimated revenue potential: USD 100-200 million in initial markets, assuming rapid clearance and adoption.

• Mid-term (2026-2030):

  • Broader market penetration as Phase III trials validate safety and efficacy.
  • Expansion into chronic pain management protocols, with possible integration into combination therapies.
  • Potential for licensing and partnership deals with larger pharma entities.
  • Projected cumulative revenue: USD 1 billion+, especially if positioning as a first-in-class abuse-deterrent analgesic.

• Long-term (2030+):

  • Sustained growth as safety profiles solidify and new formulations are developed.
  • Expansion into global markets, modified formulations, and potential indications like cancer pain or post-surgical analgesia.
  • Market share capture estimated at 15-20% of the opioid submarket for safety-focused analgesics.

Strategic Opportunities and Challenges

• Opportunities:

  • Early market entry as a safer opioid alternative.
  • Building a portfolio with abuse-deterrent and multi-indication formulations.
  • Collaborations with healthcare providers and payers that prioritize safety.

• Challenges:

  • Regulatory delays or rejections due to safety concerns.
  • Competitive pressure from existing and pipeline products.
  • Pricing and reimbursement negotiations, especially in cost-sensitive markets.

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Key Takeaways

• Progress in clinical development: TARGINIQ has demonstrated promising safety and efficacy signals in early-phase trials, with Phase II ongoing and top-line data expected soon.
• Market positioning: The drug aims to fill a crucial void in the pain management landscape by offering an abuse-deterrent, safer analgesic alternative aligned with regulatory and public health priorities.
• Competitive edge: Its focus on safety, abuse deterrence, and multi-indication potential differentiate TARGINIQ from traditional opioids and some competitors.
• Strategic outlook: Successful Phase II outcomes and regulatory approvals could position TARGINIQ as a market leader in next-generation analgesics, with substantial revenue prospects in a rapidly evolving market.
• Operational considerations: Timely clinical data release, regulatory engagement, and partnership development will be critical to capitalize on emerging market opportunities.

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FAQs

1. When is TARGINIQ expected to complete its clinical trials?
Top-line Phase II results are anticipated by early 2024. Subsequent Phase III trials, if initiated, could extend through 2025, aiming for regulatory submission shortly thereafter.

2. What differentiates TARGINIQ from existing opioid analgesics?
TARGINIQ emphasizes safety through its abuse-deterrent formulation and potentially reduced dependency risk, aligning with regulatory emphasis on safer pain management options.

3. What regulatory hurdles could impact TARGINIQ’s market entry?
Regulatory agencies may require extensive safety data, particularly on dependency potential, abuse-deterrence efficacy, and long-term safety, potentially delaying approval.

4. How does TARGINIQ's market potential compare to other pain management innovations?
Given the opioid epidemic's impact, TARGINIQ’s focus on safety confers a significant advantage, positioning it favorably compared to traditional opioids and less advanced formulations.

5. What strategic partnerships could accelerate TARGINIQ’s success?
Collaborations with biotech firms specializing in abuse-deterrent technologies, healthcare providers, and payers could facilitate faster adoption and broader market penetration.

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Sources

1. MarketsandMarkets, "Pain Management Market by Product, Application, and Region," 2021.
2. IQVIA Institute, "Global Insights on Pain Management," 2022.
3. U.S. Food & Drug Administration, "Guidance for Industry: Abuse-Deterrent Opioids," 2015.
4. EvaluatePharma, "Analgesics Market Analysis," 2022.
5. GlobalData, "Opioids Market Dynamics," 2022.

[Note: All data points and projections are based on available public information, industry analysis, and trends as of early 2023.]