Solasia Announces Submission of New Drug Application for Anti-cancer Drug DARINAPARSIN for Peripheral T-Cell Lymphoma in Japan
Solasia Pharma K.K. (TSE: 4597, Headquarters: Tokyo, Japan, President & CEO: Yoshihiro Arai, hereinafter “Solasia”) today announced submission of a New Drug Application (NDA) for its new anti-cancer drug darinaparsin (generic name, development code: SP-02) as a treatment for relapsed or refractory peripheral T-cell lymphoma to the Ministry of Health, Labour and Welfare (MHLW). Based on positive results of R&D on darinaparsin, centered primarily on the results of the Asian Multinational Phase 2 Study (study results released in June 2020), Solasia filed an NDA for the drug with the regulatory authority in Japan ahead of anywhere else in the world.
Solasia expects to obtain regulatory approval in 2022 and to also launch in the same year. If approved and launched, darinaparsin would be the third drug Solasia successfully developed and brought to market since its founding and is expected to contribute to the treatment of PTCL.
Mr. Yoshihiro Arai, President and CEO of Solasia, commented as follows:
“No standard treatment has been established for relapsed or refractory PTCL as of yet. I firmly believe that darinaparsin, with its novel mechanism of action that differs from those of already approved drugs, will contribute to patients and healthcare providers at clinical sites as a new treatment option for relapsed or refractory PTCL. Since founding, Solasia has conducted R&D on five pipeline drugs. Of the five, we have successfully developed and brought to market two drugs, i.e., began providing them to patients, and today, we submitted an NDA for our first anti-cancer drug. Under our mission to provide patients with ‘Better Medicine for a Brighter Tomorrow’, we will continue aiming to contribute to patients’ treatment and enhanced quality of life. ”
About darinaparsin (SP-02)
Darinaparsin, an organoarsenic compound with anticancer activity, is a novel mitochondrial-targeted agent being developed for the treatment of various hematologic and solid tumors. The proposed mechanism of action of the drug involves the disruption of mitochondrial function, increased production of reactive oxygen species, and modulation of intracellular signal transduction pathways. Darinaparsin is believed to exert anticancer effect by inducing cell cycle arrest and apoptosis. Darinaparsin has been granted orphan drug designation in the US and EU.
For more information, please visit at https://solasia.co.jp/en/pipeline/sp-02.html
About Asian Multinational Phase 2 Study
The Asian Multinational Phase 2 Study was a multinational, multicenter, single-arm, open-label, non-randomized study to evaluate the efficacy and safety of darinaparsin monotherapy in patients with relapsed or refractory PTCL conducted in Japan, Korea, Taiwan, and Hong Kong. (CT.gov Identifier: NCT02653976).
Solasia plans to present the results of the study at an international academic conference to be held in the near future.
About peripheral T-cell lymphoma (PTCL)
Please visit at https://solasia.co.jp/en/pipeline/sp-02.html
About Solasia
Please visit at https://solasia.co.jp/en/
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210630005395/en/
Contact information
Solasia Pharma K.K.
Rie Toyoda, Public Relations and Investor Relations,
Tel. +81 3 5843 8049
info@solasia.co.jp
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Two Young Chefs Have Passed the Japanese Cuisine Certification Exam (Organized by JCDC) and Have Newly Acquired Gold Certification!21.3.2025 15:00:00 CET | Press Release
The Japanese Cuisine and Dietary Culture Development Committee (JCDC) (Location: Minato-ku, Tokyo; Representative: Yoshihiro Murata; Website: https://en.jcdc.tokyo/), which supports and promotes the spread of Japanese food overseas, held a certification exam for foreign chefs in Kyoto. This certification exam is based on the “Guidelines for Certification of Cooking Skills for Japanese Cuisine in Foreign Countries” (enacted on April 1, 2016 / revised on April 1, 2024) established by the Ministry of Agriculture, Forestry and Fisheries (MAFF) of Japan. In this examination, two people from Vietnam, Le Minh Tien and Pham Duc Duy, successfully obtained Gold certification. In addition, the two foreign chefs who came to Japan to participate in the Kyoto final of the “Road to Japanese Culinary Arts Award 2024-2025” hosted by the Japanese Culinary Academy were also certified as Silver. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/2025
DEWA’s General Assembly Approves Dividend Payment of AED 3.1 Billion to Shareholders for H2 of 202421.3.2025 14:34:00 CET | Press Release
Dubai Electricity and Water Authority PJSC (ISIN: AED001801011) (Symbol: DEWA), the Emirate of Dubai’s exclusive electricity and water services provider, which is listed on the Dubai Financial Market (DFM), reported that its shareholders have, in the general assembly held on 21 March 2025, approved the payment of total dividend of AED 3.1 billion for H2 of 2024, with a record date of 31 March 2025. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250321365368/en/ During DEWA’s General Assembly (Photo: AETOSWire) The meeting, chaired by HE Matar Humaid Al Tayer, Chairman of the Board of Directors of DEWA, was attended by HE Saeed Mohammed Al Tayer, MD & CEO of DEWA, and Members of the Board of Directors of DEWA as well as 92.2% of the shareholders. During the meeting, a Board of Directors was elected for the next three years. For shareholders who are invested in DEWA’s shares prior to the dividend record date of 31 March 2025 (
Ecolab Delivers on Commitments to Save Water in Historic AI Era21.3.2025 12:00:00 CET | Press Release
Water is the world’s most essential resource, and it’s only grown more critical in the age of AI. During this transformative digital revolution, Ecolab, a global sustainability leader that maximizes growth and performance through water solutions and infection prevention services, has continued to meet its goals and work with customers to deliver profitability while advancing optimized water use. By 2030, it is estimated that AI-related growth will demand additional power equivalent to the annual needs of India1 and as much water to meet the annual drinking water needs of the United States2. As the world navigates the growth of AI and high-tech data centers, there is a unique opportunity to leverage AI to help drive efficiency and innovation in circular water management to improve operational processes and conserve natural resources. Ecolab’s mission to help protect water while driving business growth is more important than ever. “The rapid acceleration of AI technology is increasing de
Galderma Publishes its 2024 Annual Report and the Invitation to Its First Annual General Meeting21.3.2025 07:00:00 CET | Press Release
Galderma Group AG (SIX: GALD), the pure-play dermatology category leader, today published its 2024 Annual Report along with the invitation to its first Annual General Meeting which will be held on April 23, 2025. Galderma’s 2024 Annual Report, the 2024 Finance Report and the invitation to the Annual General Meeting are available on Galderma’s Investor Relations website at https://investors.galderma.com/. About Galderma Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals
Almirall's 16 th Skin Academy Brings Together Leading Experts to Advance Skin Science and Treatment Options in Medical Dermatology21.3.2025 07:00:00 CET | Press Release
Almirall, a global pharmaceutical company dedicated to medical dermatology hosts the 16th edition of Skin Academy, a premier conference for healthcare professionals in the field of dermatology. This year's event features a comprehensive program aimed at sharing state-of-the-art scientific knowledge on skin diseases, their treatment, and clinical best practice. The Skin Academy is a unique opportunity for collaboration, bringing together a broad range of leading experts and clinicians from across the globe to create a network of peers that discuss and learn together to advance the treatment of skin diseases. The event will foster collaboration and co-creation of innovative approaches and solutions to better respond to the unmet needs of the millions of people living with dermatological conditions. Prof. Dr. Ulrich Mrowietz, from the Psoriasis Center at the University Medical Center Schleswig-Holstein, Campus Kielin Germany said: "deep collaboration across experts is essential for advanc
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom