June 2, 2025

Location: New Delhi, India

Denik Pharm Co Ltd Launches HEPTRA NOVA®: A Groundbreaking FDA-Approved Liver Support Therapy

Combining Resmetirom, TUDCA & NAD+ (Clinically Proven for NAFLD/NASH)

Denik Pharm Co Ltd proudly announces the official launch of HEPTRA NOVA®, a novel, clinically proven liver support medicine formulated with Resmetirom (the first FDA-approved therapy for NASH), TUDCA (Tauroursodeoxycholic Acid), and NAD+ (Nicotinamide Adenine Dinucleotide). This revolutionary product aims to transform liver health treatment for millions suffering from Non-Alcoholic Fatty Liver Disease (NAFLD) and its progressive form, Non-Alcoholic Steatohepatitis (NASH), which is rapidly emerging as a global health crisis.

Understanding Liver, Its Function, and Complications

• The liver is the body’s metabolic powerhouse — filtering toxins, regulating blood sugar, metabolizing fats, and producing essential proteins.
• For everyday individuals, liver health ensures sustained energy, strong immunity, and balanced metabolism.
• For fitness-driven lifestyles, the liver plays a critical role in endurance, muscle recovery, and performance optimization.
• Conditions like NAFLD and NASH impair mitochondrial function, deplete NAD+, and increase oxidative stress, reducing the liver’s ability to repair itself.
• Resmetirom, an FDA-approved selective THR-β agonist, directly reduces liver fat while controlling inflammation — addressing two root causes of fatty liver progression.
• Without timely treatment, fatty liver can silently progress to fibrosis, cirrhosis, hepatocellular carcinoma (HCC), or even liver failure.

Effects of Fatty Liver or Compromised Liver

• A compromised liver disrupts energy balance, hormonal regulation, and detoxification, leading to fatigue and poor immunity.
• In everyday life, this increases the risk of obesity, type 2 diabetes, cardiovascular disease, and metabolic syndrome.
• In active lifestyles, impaired liver health reduces stamina, slows muscle recovery, and diminishes overall performance.
• Progressive NAFLD/NASH can result in serious complications such as cirrhosis, portal hypertension, liver cancer, and eventually the need for transplantation.
• Research shows that restoring NAD+ for mitochondrial energy, protecting cells with TUDCA, and reducing fat + inflammation with Resmetirom creates a 360° shield for liver protection.
• By addressing fat accumulation, oxidative stress, and fibrosis simultaneously, HEPTRA NOVA® offers a holistic solution for maintaining long-term liver health and peak physical resilience.

The Urgency: NAFLD/NASH as a Global Health Burden

• NAFLD affects over 25% of the global adult population.
• In India, prevalence is estimated at 30–35%, with urban populations at higher risk due to sedentary lifestyles and dietary patterns.
• NASH, the severe inflammatory form, can progress to cirrhosis, liver failure, or hepatocellular carcinoma (HCC) if untreated.
• The WHO estimates that by 2030, NASH will become the leading cause of liver transplantation worldwide.

Despite the scale of this crisis, effective pharmacological treatments have been limited. Lifestyle modification alone has not been sufficient to curb progression in most patients. This unmet need has paved the way for novel therapeutic strategies like HEPTRA NOVA®.

Introducing HEPTRA NOVA®

HEPTRA NOVA® is a multi-targeted liver health innovation that brings together:

• Resmetirom – FDA-approved, first-in-class, liver-directed selective thyroid hormone receptor-β (THR-β) agonist proven to reduce liver fat and inflammation.
• TUDCA (Tauroursodeoxycholic Acid) – a cytoprotective bile acid derivative with strong anti-apoptotic, antioxidant, and anti-fibrotic properties.
• NAD+ – a vital coenzyme for mitochondrial energy production, essential for cellular repair, detoxification, and slowing liver aging.

This triple synergy makes HEPTRA NOVA® more than just a medication—it is a comprehensive liver support therapy designed to tackle fat accumulation, oxidative stress, mitochondrial dysfunction, and fibrosis simultaneously.

Scientific Validation: Resmetirom (MGL-3196) Clinical Trials

MAESTRO-NASH Trial (2023, NEJM Publication)

• Design: Phase 3, double-blind, placebo-controlled trial across multiple countries.
• Population: Over 2000 patients with biopsy-confirmed NASH.
• Results: 25–30% reduction in liver fat within 12 weeks. Significant improvement in NASH resolution without worsening of fibrosis. Achieved ≥2-point reduction in NAS (NAFLD activity score). Well tolerated, with mild GI symptoms being the most reported side effect.

MAESTRO-NAFLD-1 Trial

• Demonstrated rapid and sustained reduction of liver fat (MRI-PDFF measurements).
• Improvements in lipid profile, including LDL cholesterol reduction.

These robust results led to FDA approval of Resmetirom in 2024, marking a historic milestone in liver therapeutics.

The Power of TUDCA

TUDCA, a hydrophilic bile acid, has been extensively studied for its role in liver and metabolic health:

• Anti-apoptotic effects: Prevents hepatocyte death induced by oxidative and ER stress.
• Anti-fibrotic: Inhibits stellate cell activation and collagen deposition.
• Mitochondrial support: Enhances mitochondrial membrane stability.

Clinical data: Used for decades in cholestatic liver disease. Trials show improvement in ALT, AST, and GGT levels in NAFLD patients. Synergistic effects when combined with antioxidants and metabolic modulators.

By including TUDCA, HEPTRA NOVA® provides added protection against fibrosis progression, a key determinant of patient survival.

NAD+: The Cellular Energy Currency

NAD+ levels naturally decline with aging, obesity, and chronic disease. In liver disorders, NAD+ deficiency accelerates oxidative stress and mitochondrial dysfunction.

• Restores mitochondrial energy metabolism.
• Activates sirtuins (SIRT1, SIRT3), regulating inflammation, fat oxidation, and insulin sensitivity.
• Enhances DNA repair mechanisms, protecting hepatocytes from injury.
• Preclinical and human studies suggest NAD+ supplementation reverses metabolic dysfunction and reduces liver fat accumulation

Together with Resmetirom and TUDCA, NAD+ provides the missing cellular energy boost for effective recovery.

How HEPTRA NOVA® Works – A 360° Liver Protection Model

• Fat Reduction – Resmetirom stimulates hepatic fat oxidation, reducing steatosis.
• Inflammation Control – TUDCA lowers oxidative and ER stress.
• Fibrosis Prevention – Both Resmetirom and TUDCA reduce fibrogenesis.
• Mitochondrial Revitalization – NAD+ restores energy metabolism.
• Cardio-metabolic Benefits – Resmetirom improves lipid profile.

This multi-pronged approach sets HEPTRA NOVA® apart from conventional single-agent therapies.

Transforming Liver Care

For decades, liver health therapies were restricted to lifestyle modifications and limited symptomatic relief. With the arrival of HEPTRA NOVA®:

• Patients gain access to the first clinically proven, FDA-approved NASH therapy in combination with liver-protective and energy-restoring agents.
• Physicians receive a trusted, evidence-backed option to halt progression at early stages.
• Healthcare systems benefit by reducing the long-term burden of cirrhosis, liver transplant, and cancer.

Expert & Leadership Commentary

“HEPTRA NOVA® is more than a product launch—it is a paradigm shift in how we approach liver diseases. By combining Resmetirom's FDA-proven benefits with the synergistic protection of TUDCA and NAD+, we are delivering a comprenhensive solution that patients and doctors have been waiting for.” — Denik Pharm Co Ltd.

“The approval of Resmetirom marked the dawn of a new era in hepatology. HEPTRA NOVA® builds upon that foundation, ensuring broader and more sustainable protection for the liver. We believe this therapy can rewrite the futire of NAFLD and NASH management..” — Dr. S Kahnpisey, Senior Consultant, Hepatology

Market Potential & Accessibility

• India has an estimated 120 million people living with NAFLD, many progressing silently to NASH.
• Global Market: The NASH therapeutics market is projected to exceed USD 20 billion by 2030.
• HEPTRA NOVA® will be made accessible at competitive pricing to ensure patients across developing countries benefits from advanced liver therapy.

Denik Pharm Co Ltd is commited to bridging global innovation with local accessibility.

About Denik Pharm Co Ltd

Founded in 2016, Denik Pharm Co Ltd is a leader in nutraceuticals, rDNA medicines, and advanced therapeutics. With a mission to deliver high-quality healthcare products at affordable prices, the company has poineered launches in peptides, growth factors, and now in revolutionary liver therapeutics.

Call to Action

HEPTRA NOVA® is now available through leading hospitals, specialized hepatology centers, and authorized distributors. Physicians and healthcare providers are encouraged to learn more through dedicated medical education sessions, webinars, and clinical resource materials provided by EL Farmaceutica.

🌐 For more details, visitwww.elfarmaceutica.com
📞 +91 9870192442

Conclusion

HEPTRA NOVA® represents hope, innovation, and transformation in liver health. With the strength of Resmetirom's FDA-approved clinical foundation, the protective power of TUDCA, and the energy restoration of NAD+, it is poised to become the gold standard in NAFLD/NASH management.

This launch marks not just a product milestone, but a new era in global liver care.

Frequently Asked Questions

Q1. What makes HEPTRA NOVA® different from other liver medicines?

A: It combines FDA-approved Resmetirom with TUDCA and NAD+, delivering three-dimensional action: reducing liver fat, protecting against fibrosis, and restoring enegy at the cellular level.

Q2. Is it for safe long-term?

A: Yes. Resmetirom is well-tolerated; with only mild gastrointestinal side effects. TUDCA and NAD+ are manuaaly occuring compounds with strong safety records.

Q3. Who can benefit?

A: Patients with NAFLD/NASH, fatty liver due to obesity/diabetes, or those at risk of cirrhosis.

Q4. How soon can I see results?

A: Resmetirom trials show significant fat reduction in 12 weeks, with improvements continuing over time.

Why HEPTRA NOVA® Matters

👉 Targets every angle of liver disease — Fat, Inflammation, Fibrosis, Mitochondrial Dysfunction, and Cardio-metabolic Risk.

Patient Success Story

“I was diagnosed with fatty liver two years ago and was told there was no effective medicine. After HEPTRA NOVA®, my liver values improved in just 3 months. Today, I feel more energetic, digestion is better, and my doctor says my risk of cirrhosis has reduced.” — Bhuwan Sharma, 42, New Delhi