Zydus

Zydus and Beihai Biotech Announce Joint Venture to Commercialize BEIZRAY in the US Market

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Zydus Cadila, a leading Indian pharmaceutical company, has signed an agreement with Beihai Biotech, a Chinese biotech company, to commercialize Beihai’s novel currently G1, a biosimilar version of Zenpepi, in the US market. This agreement marks a significant milestone in the company’s global expansion plans, as it seeks to increase its presence in the US market.

BEIZRAY, the biologic equivalent of Zenpepi, is a humanized monoclonal antibody that targets the IL-23 pathway, currently G1, being developed by Beihai Biotech for the treatment of moderate to severe plaque psoriasis. The drug has shown promising results in clinical trials, demonstrating improved efficacy and safety profiles compared to the originator product.

Under the terms of the agreement, Zydus Cadila will commercialize BEIZRAY in the US, leveraging its established distribution network and regulatory expertise to secure necessary approvals. Beihai Biotech, on the other hand, will retain global rights to BEIZRAY, with the exception of the US market.

This partnership is a win-win for both companies, as it enables Zydus Cadila to expand its pipeline of biosimilars and further strengthen its presence in the US market. For Beihai Biotech, this agreement provides a platform to tap into the significant US market, one of the world’s largest pharmaceutical markets.

The development of biosimilars is a significant area of interest in the pharmaceutical industry, as they offer cost-effective alternatives to originator products, making them more accessible to patients worldwide. With this agreement, Zydus Cadila and Beihai Biotech are poised to make a meaningful impact in the treatment of psoriasis and other autoimmune disorders in the US.

The agreement is testament to the growing collaboration between Indian and Chinese companies in the pharmaceutical space. As the competition continues to intensify, Indian and Chinese companies are increasingly partnering to leverage each other’s strengths, expertise, and resources to drive growth and innovation. This agreement is a significant milestone in the ongoing efforts to develop more affordable and accessible medical treatments for patients worldwide.

Zydus receives Zero-Defect Audit Clearance at its Ambernath facility, demonstrating exceptional quality and compliance with US FDA standards.

Zydus Lifesciences Ltd has received a “No Observation” from the US Food and Drug Administration (US FDA) following a surveillance inspection of its API manufacturing facility in Ambernath, Maharashtra. This is a significant achievement, as it demonstrates the company’s compliance with US pharmaceutical manufacturing regulations. The company’s formulation sales in the US market reached USD 285 million in the third quarter of fiscal year 2025, a 29% year-over-year (YoY) increase, exceeding market estimates of USD 270 million.

The company’s Q3 FY25 revenue grew 17% YoY to ₹5,269 crore, driven by strong performance across all segments. Net profit jumped 30% YoY to ₹1,023 crore, boosted by improved forex gains and robust sales increase. The company’s forex gain was ₹183 crore, a significant improvement from ₹21 crore in the same period last year. Earnings before interest, taxes, depreciation, and amortization (EBITDA) increased to ₹1,387 crore, reflecting improved operational efficiency and cost management.

The company’s EBITDA margin expanded 200 basis points to 26.3%, demonstrating better cost management and increasing profitability. The net debt to equity ratio improved to negative 0.14 times as of December 13, compared to negative 0.47 times last year, indicating a solid financial position. Overall, Zydus Lifesciences Ltd’s performance is strong, with revenue and profit growth driven by the US market, robust sales, and improved foreign exchange gains, underscoring its solid financial position.

Zydus Lifesciences’ API Manufacturing Unit in Ambernath Secures Clearance from the US FDA after Successful Inspection

Zydus Lifesciences recently announced that the US Food and Drug Administration (USFDA) conducted a surveillance inspection at the company’s Active Pharmaceutical Ingredients (API) manufacturing site in Ambernath, Maharashtra, India. The inspection took place from February 10th to 14th, 2023. After concluding the inspection, the USFDA found zero (NIL) issues or observations, indicating a clean bill of health for the site.

This is a significant achievement for Zydus Lifesciences, as USFDA inspections can be thorough and rigorous, and zero observations is a testament to the site’s quality, quality control, and compliance with good manufacturing practices (GMPs). The API manufacturing site at Ambernath is a key part of Zydus Lifesciences’ operations, producing high-quality APIs that are used as raw materials in the production of various pharmaceutical products.

The USFDA’s surveillance inspections are designed to ensure that pharmaceutical companies like Zydus Lifesciences maintain high standards of quality and compliance with regulations. The agency conducts regular inspections to assess a company’s manufacturing practices, facilities, and quality control processes. By achieving a NIL inspection, Zydus Lifesciences demonstrates its commitment to excellence and adherence to the highest standards of quality and regulatory compliance.

This successful inspection is a significant milestone for Zydus Lifesciences, as it reinforces the company’s reputation for producing high-quality APIs and upholds its commitment to transparency and compliance. The company’s ability to maintain high standards of quality and GMPs is crucial for the production of safe and effective pharmaceuticals, and this inspection outcome is a testament to Zydus Lifesciences’ dedication to upholding the highest standards in the industry.

Zydus Forsclife, a leading Indian pharmaceutical company, has formed a partnership with a Dutch research firm to co-develop a groundbreaking new cancer treatment.

Zydus Lifesciences has entered into an exclusive agreement with Synthon BV, a Dutch company, to develop, license, supply, and commercialize a novel oncology product. The product is intended to address an unmet need in the market and has the potential to reach a $1.5 billion market size in the US alone. Under the agreement, Synthon will be responsible for developing, manufacturing, and supplying the finished product, while Zydus will focus on submitting a New Drug Application (NDA) and commercializing the product in the US. The product is expected to be filed in 2026 and offers several advantages, including reduced pill burden, flexibility for dose adjustment, and enhanced patient compliance.

This partnership is seen as a strategic move by both companies, with Zydus Lifesciences looking to expand its presence in the oncology space and Synthon BV building on its capabilities in complex product development. Zydus Lifesciences’ MD, Sharvil Patel, highlighted the importance of the partnership in bringing access to high-need therapy areas, while Synthon BV’s CEO, Anish Mehta, emphasized the company’s expertise in developing complex and clinically differentiated products.

The agreement is a significant development for both companies, with the potential to generate significant revenue and expand their global reach. The agreement also demonstrates the success of the two companies in partnering to bring innovative treatments to patients. With the global pharmaceutical market expected to continue growing, this partnership is likely to be a significant step forward for both Zydus Lifesciences and Synthon BV, and ultimately, patients suffering from oncological diseases.

Zydus Cadila and ReNetX Leverage Advancements in Spinal Cord Injury Therapeutics, Propelling the Market Towards Robust Growth by 2025-2032.

The spinal cord injury (SCI) therapeutics market is expected to witness significant growth from 2025 to 2032, driven by the increasing number of SCIs, rising awareness of the need for effective treatment options, and advancements in research and development (R&D).

According to a report by Zydus Cadila, a leading Indian pharmaceutical company, the global SCIs market is projected to reach a value of $1.8 billion by 2025, growing at a CAGR of 14.5% during the forecast period. ReNetX, a leading developer of therapeutics for SCIs, has also predicted that the market will reach $2.2 billion by 2032, growing at a CAGR of 18.1% during the same period.

The growth of the SCIs market is driven by several factors, including:

1. Increasing number of SCIs: SCIs are a major health concern, with over 12,000 new cases reported every year in the United States alone.
2. Rising awareness: Awareness campaigns and public education initiatives are increasing, leading to a greater understanding of the importance of timely intervention and effective treatment.
3. Advancements in R&D: Research and development are leading to the development of new and innovative treatments, such as stem cell therapy, gene therapy, and immunotherapies.
4. Increasing demand for alternative treatment options: Patients are seeking alternative treatment options, leading to a growing demand for investigational new drugs (INDs) and personalized therapies.

The market is also being driven by the presence of key players such as Allergan, Merck, Pfizer, and F Hoffmann-La Roche.

The report also highlights the challenges faced by patients with SCIs, including:

1. Limited treatment options: Current treatment options are limited, leading to a high unmet need for effective therapies.
2. High costs: The high cost of treatment and long-term care can be a significant financial burden for patients.
3. Limited accessibility: Access to specialized care and rehabilitation services can be limited in some regions, leading to a lack of uniform treatment and care.

To address these challenges, researchers are focusing on the development of new and innovative treatments, including:

1. Gene therapy: Gene therapy shows promise in promoting neural repair and regeneration.
2. Immunotherapy: Immunotherapy can help stimulate the body’s natural repair processes.
3. Stem cell therapy: Stem cell therapy can help replace damaged tissue and promote repair.

The report concludes that the SCIs market is poised for significant growth, driven by advancements in R&D, increasing awareness, and the need for effective treatment options. However, challenges remain, including limited treatment options, high costs, and limited accessibility.

The 6th X-CIPLOG Reunion, taking place in 2025, commemorated the year with its events in Mumbai.

The 6th X-CIPLOG Reunion Event 2025, organized by Ex-Cipla, an association of over 500 ex-employees with Cipla, was held in Worli, Mumbai, and celebrated the achievements of 12 distinguished professionals and three pharma organizations of international repute – Cipla, Serum, and Zydus. The event aimed to foster industry-wide collaboration, innovation, and camaraderie while honoring exemplary contributions.

The reunion featured several insightful sessions, including tech talks on emerging digital technologies, panel discussions on work-life balance, and a session on working with multiple companies with different cultures. The event also featured an award ceremony, where Cipla was recognized for its breakthrough in drug delivery through inhalation, including the approval of Afrezza, an inhalable insulin.

The Innovation and Career Excellence Awards 2025 were conferred upon three pharmaceutical organizations – Serum Institute of India for its leadership and innovation in vaccine technology, and Zydus Cadila, honored for its CEO Pankaj Patel’s Padma Bhushan award. The individual awards were given to professionals in various fields, including R&D, marketing, quality assurance, export management, and research and development.

Each awardee was recognized for their outstanding contributions to the pharmaceutical industry, aligning with the vision of “Together We Can Keep the World Healthy.” The event concluded with a renewed commitment to driving advancements in pharmaceuticals for a healthier future.

Zydus Takeda will extend its product range through the acquisition of new active pharmaceutical ingredients (APIs) and key sensitive molecules (KSMs).Let me know if you’d like me to rephrase it in a different way!

Zydus Takeda Healthcare Private Limited, a joint venture between Zydus Lifesciences Limited and Takeda Pharmaceutical Company Limited, recently celebrated its 25th anniversary at its Vashi manufacturing plant in India. Established in 1995, the site has developed into a significant supplier of Active Pharmaceutical Ingredients (APIs) and key starting materials (KSMs) for Takeda’s European, Japanese, Brazilian, and Korean markets. The 100% export-oriented unit has consistently prioritized safety and quality, successfully completing capacity enhancements and multiple tech transfers for key small molecule products.

As the site looks towards the future, Zydus Takeda aims to further elevate its role within Takeda’s strategic network by implementing various initiatives. These include the expansion of the product portfolio, enhancement of kilo lab facilities, and transition to renewable energy to support Takeda’s net-zero emissions goal. The company is also investing in digital automation technologies to improve efficiency and reduce waste, as well as developing new supply chain strategies and prioritizing employee engagement through continuous learning.

Additionally, Zydus Takeda is focused on advancing initiatives centered around health and environmental sustainability. The company is committed to reducing waste, conserving resources, and promoting sustainable practices, aligning with Takeda’s global goals. Looking back, the Vashi site has undergone significant growth, establishing itself as an important manufacturing arm within Takeda’s network. With its success as a supplier of APIs and intermediates, Zydus Takeda is poised to continue its journey towards a sustainable future, ensuring the delivery of high-quality products while minimizing its environmental impact.

Commemorating 25 years of unwavering commitment to excellence and innovation, Zydus Takeda Healthcare celebrates a milestone in its Indian manufacturing journey.

Zydus Takeda Healthcare Private Limited, a joint venture between Zydus Lifesciences Limited and Takeda Pharmaceutical Company Limited, is celebrating the 25th anniversary of its manufacturing plant in Vashi, India. This milestone marks the company’s commitment to producing high-quality active pharmaceutical ingredients (APIs) and intermediates for life-transforming treatments for patients globally. Over the past 25 years, the Vashi plant has emerged as a key supplier of APIs and intermediates for Takeda’s markets in Europe, Japan, Brazil, and Korea. The plant has a strong focus on safety and quality, with a team that has successfully executed capacity enhancements and multiple tech transfers for key Takeda small molecule products.

Looking ahead, Zydus Takeda aims to elevate the site’s role within Takeda’s network by expanding its product portfolio, enhancing kilo lab facilities, transitioning to renewable energy, and investing in digital automation technologies to improve efficiency and reduce waste. The company also plans to develop new supply chain strategies, strengthen global collaboration, and drive employee engagement through continuous learning and development.

The 25th anniversary celebration is also a recognition of the dedicated team at Vashi, who have driven the site’s success through their expertise and adaptability. The team is committed to the shared values of Zydus and Takeda, which include patient centricity, trust, reputation, adaptability, excellence in execution, innovation, collaboration, respect, and integrity. The company plans to continue upholding these values as it moves forward.

Pankaj R Patel, Chairman of Zydus Lifesciences, has been conferred the prestigious Padma Bhushan award.

Pankaj R Patel, Chairman of Zydus Lifescience, has been honored with the prestigious Padma Bhushan award by the Government of India. This recognition is a testament to his dedication and contributions to the Indian lifescience industry. With a Master’s degree in Pharmaceutics and Pharmaceutical Technology and an alumnus of the Indian Institute of Management (IIM), Ahmedabad, Patel has a strong background in both research and commercial expertise.

Throughout his career, Patel has been driven by a passion to become a pharma entrepreneur and has published over 100 research papers in peer-reviewed journals. He is also a co-inventor in over 64 patents. As the Chairman of Zydus Lifescience, he has led the company to become a leader in the Indian pharma industry, with its 27,000-strong workforce committed to putting India at the forefront of innovation and addressing unmet healthcare needs.

Patel’s honors and memberships are a testament to his reputation as a respected leader in the industry. He is a member of the Reserve Bank of India’s board, Chairperson of the Board of Governors of IIM Ahmedabad and Chairman of IIM Udaipur, and Chairman of several not-for-profit and charitable institutions. He is also the Executive Chairman of the Gujarat Cancer Society and Chairman of the Gujarat Cancer and Research Institute, which provides care and support to underprivileged cancer patients.

Patel’s philanthropic efforts are equally impressive, with his Zydus Foundation supporting various initiatives, including education, pharmaceutical technology, innovation, sustainable livelihoods, water conservation, skill development for disadvantaged groups, and green initiatives for sustainability. He has also set up Zydus Hospital and Medical College in Dahod, which provides vital healthcare services to the region.

In his acceptance speech, Patel expressed his gratitude for the recognition and committed to continue his work in the pharma industry, saying, “We are taking a leap into the future with the convergence of health, digital advancements and technology. Innovation from India will bring critical access to affordable healthcare and empower people to lead healthier and more fulfilled lives.” With his many achievements and continued commitment to the pharma industry, Pankaj R Patel is an inspiration to many, and his Padma Bhushan award is a well-deserved recognition of his outstanding contributions.

The Zydus Lifesciences Chairman is over the moon with pride as he receives the prestigious Padma Bhushan honour

Dr. Jitu Vaidya, the Chairman of Zydus Lifesciences, has expressed his immense gratitude for being conferred the prestigious Padma Bhushan award, one of the highest civilian honors given by the Government of India. This recognition is a testament to his outstanding contributions to the pharmaceutical industry and his philanthropic efforts.

Vaidya, who is also a pioneer in the field of pharmaceuticals in India, has been instrumental in transforming Zydus into a leading player in the industry. His innovative approach to business and commitment to quality have earned the company a strong reputation both in India and globally.

The Padma Bhushan award is a significant acknowledgment of Vaidya’s leadership and vision, which has not only driven business growth but also had a positive impact on the lives of millions of people. Under his leadership, Zydus has been at the forefront of introducing innovative medicines and technologies that have improved healthcare outcomes in India.

Vaidya’s commitment to philanthropy is another large part of his work. He has been actively involved in several social and charitable initiatives, including education, health, and community development. His philanthropic efforts have helped improve the lives of many underprivileged individuals and communities.

Vaidya’s success can be attributed to his strong leadership skills, innovative thinking, and passion for his work. His achievements are a reflection of his dedication to his profession and his commitment to making a positive impact on society.

The Zydus Group, under Vaidya’s leadership, has received numerous awards and accolades over the years, including the “Best Company in India” award, “Best Pharmaceutical Company” award, and the “Outstanding Contribution to Industry” award.

Vaidya’s recognition as a Padma Bhushan awardee is a proud moment for Zydus Lifesciences and the entire Zydus family. His recognition is a testament to his leadership, vision, and commitment to making a difference in the lives of others.

Zydus clears the way for US clinical trials of oral medicine, Sofronlast, designed to treat amyotrophic lateral sclerosis (ALS).

Zydus Lifesciences has been cleared by the US Food and Drug Administration (FDA) to initiate a Phase 2b clinical trial for its experimental oral treatment, usnoflast, in patients with amyotrophic lateral sclerosis (ALS). The double-blind, placebo-controlled trial is expected to enroll 210 ALS patients who will receive either 50mg or 75mg of usnoflast or a placebo for 36 weeks. The main goal of the trial is to determine if usnoflast can slow the progression of ALS, as measured by declines in the ALS Functional Rating Scale Revised (ALSFRS-R) over the initial 36 weeks.

Usnoflast, previously known as ZYIL1, is an orally available small molecule designed to reduce inflammation by blocking the NLRP3 inflammasome, a group of proteins that contributes to disease-driving inflammation in people with ALS. The trial follows a previous Phase 2a trial in India, which showed promising results in slowing disease progression and improving safety.

The Phase 2b trial will assess changes in lung function and levels of ALS biomarkers, and participants will have the option to enter an open-label extension part to continue receiving the experimental therapy for an additional 16 weeks. The trial is led by Merit Cudkowicz, MD, director of the Sean M. Healey & AMG Centre for ALS, and is expected to provide valuable insights into the potential of usnoflast in slowing the progression of ALS. Zydus chairman Pankaj Patel stated that the company is committed to developing transformative breakthrough medicines, and the trials of usnoflast are an important step in that direction.

Zydus Lifesciences’ Dapsone Gel is subject to a voluntary recall by the US FDA.

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The US FDA (United States Food and Drug Administration) has issued a recall notice for a specific product – Zydus Lifesciences’ Dapsone Gel (7.5%) – which is used for the treatment of dermatological disorders such as acnedermatoses and others. The company has initiated this voluntary recall to address potential health risks associated with the product.

According to the FDA alert, the problem lies with an unexpected level of nitrosamines, which have been found to be present in the product exceeding the FDA-recommended limit. Nitrosamines are classified as probable human carcinogens and therefore, may lead to health hazards, including cancers and other negative health outcomes if ingested orally. As per the agency guidelines, nitrosamines must be undetectable in finished drugs. However, in this specific case, there was a gap in quality testing and quality controls that led to the failure in detecting the level of nitrosamines. Consequently, patients exposed to this substandard product face an elevated risk of harm from ingesting small amounts of contaminated product, like the residual topical ointment on hands while applying or in accidental ingestion due to insufficient child-resistant packaging or tampering with the packaging material.

Davos 2025: Novartis AG CEO confirms planned exit from Indian subsidiary, as Alkem and Dr Reddy’s engage in a competitive pursuit.

Novartis AG’s CEO Vas Narasimhan has confirmed that the company’s plan to sell its 70.6% stake in Novartis India is on track. The sale is part of a strategic review of its India operations and is expected to be completed in the next few months. Alkem Laboratories has entered advanced talks to acquire Novartis India, with other players like Dr. Reddy’s Laboratories and Zydus also in the running. Novartis Healthcare Pvt Ltd, which handles R&D and clinical trials, will remain unaffected by the sale.

Despite the divestment, Narasimhan emphasized the importance of the Indian market to Novartis’ long-term strategy. He highlighted the company’s strong R&D presence in Hyderabad and collaborations with local players like Dr. Reddy’s Laboratories. Novartis India has delivered strong financial performance, with net profit soaring 91% in the first quarter of FY24.

Narasimhan also emphasized Novartis’ global outlook, saying that 2024 was one of the company’s record years and that it expects consistent growth through the end of the decade. The company plans to launch 10 new medicines in 2025, demonstrating its ambition for global expansion.

It is worth noting that Novartis’ divestment in Novartis India is part of a broader strategic review of the company’s global operations. This move is intended to help the company focus on its core operations and drive growth through innovation. The sale of Novartis India is seen as a win-win for all parties involved, with Alkem Laboratories gaining access to a major market and Novartis gaining cash and freeing up resources for future growth initiatives.

The pharma industry is likely to experience a slow pace of profit expansion in the third quarter.

Pharmaceutical companies in India are expected to experience slower profit growth in the October-December 2024 quarter compared to the previous two quarters. According to analysts, sales growth is projected to be around 10-12% and earnings before interest, taxes, depreciation, and amortisation (EBITDA) growth of 13-15%. The growth momentum is expected to slow down due to pricing pressures and a high base effect.

Large companies such as Dr Reddy’s Laboratories (DRL) and Sun Pharma are expected to contribute to the sales growth, with DRL projected to achieve over 10% growth in its India business. Mid-sized companies like JB Pharma, Torrent Pharma, and Mankind Pharma are likely to outperform with 11-13% year-on-year (YoY) growth, driven by their chronic portfolios.

In contrast, Cipla and Zydus are expected to report relatively weaker growth of 6-8% YoY due to supply constraints and base effects. The US generics segment is projected to remain flat due to price erosion and limited significant launches.

Overall, EBITDA is expected to grow by up to 15% YoY, but margins are expected to remain flat. Cipla and DRL are likely to face margin contraction, while Sun Pharma, Lupin, and Divi’s Laboratories are expected to report strong margin expansion.

The performance of key pharma players will be closely monitored by investors, particularly with respect to their outlook and commentary on margins. Updates on DRL approval timelines for large products in the US, Biocon’s outlook following the clearance of its facilities for biosimilars, and Aurobindo Pharma’s progress towards breakeven for its Penicillin G capacity will also be crucial.

Ankleshwar’s pharma sector is rocked by yet another fire incident, casting a shadow over the industry’s safety record.

A significant fire broke out at Zydus Cadila’s Unit-2 in the industrial area of Ankleshwar, Bharuch, on Monday evening. Fortunately, there have been no reported casualties so far. The incident is under investigation, and a complaint is being filed by the GIDC Ankleshwar police station.

This latest fire incident adds to the growing concerns about frequent fires in the industrial area of Ankleshwar. Just last month, a blast at Detox India Pvt Ltd factory in the same area claimed the lives of four workers. The industrial area has witnessed several fire incidents in recent times, raising concerns about the safety measures in place.

The Disaster Prevention and Management Centre (DPMC) Fire Station is currently working to control the fire at Zydus Cadila’s Unit-2. The authorities are taking all necessary steps to prevent any further damage or injuries.

The cause of the fire is yet to be determined, but it highlights the need for greater vigilance and stricter safety measures in the industrial area. The incident also raises questions about the effectiveness of existing safety protocols and the measures being taken to prevent such incidents in the future.

The incident is a wake-up call for the authorities, industry leaders, and workers in the area. It is crucial to take a comprehensive approach to ensuring the safety and well-being of all those working in the industrial area. The authorities must investigate the incident thoroughly and take concrete steps to prevent such incidents from happening in the future.

Zydus Lifesciences secures clearance from the US FDA to commence a Phase II(b) clinical trial for Usnoflas.

Zydus, a global pharmaceutical company, has received approval from the US FDA to conduct a Phase II(b) clinical trial for Usnoflast, a novel oral NLRP3 inflammasome inhibitor, in patients with Amyotrophic Lateral Sclerosis (ALS). The trial will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of Usnoflast in 210 adult ALS patients. The primary endpoint will be the change in ALSFRS-R total score from baseline to week 36, while key secondary endpoints will include changes in Slow Vital Capacity, CSF levels of NfL, and biomarkers such as hs-CRP, IL-18, IL-6, IL-1β, NLRP3, and SAA.

ALS is a progressive neurological disease that affects approximately 32,000 people in the USA and 75,000 people in India. Patients with ALS experience rapid neurodegeneration, leading to loss of motor function, paralysis, and death. The disease is characterized by neuroinflammation and the accumulation of neurofilaments in the central nervous system.

Zydus is committed to developing transformative breakthrough medicines for neurological disorders, and this trial marks an important step towards unlocking new treatments for ALS. The company’s Chairman, Pankaj Patel, expressed excitement about the approval and commitment to neuroscience research.

The Phase II(b) trial will involve a 36-week treatment phase and a 16-week open-label extension. Patients will be randomized to receive either 50 mg or 75 mg of Usnoflast or placebo. The trial aims to provide insights into the efficacy and safety of Usnoflast in ALS patients and potentially pave the way for its approval as a treatment for this devastating disease.