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Last Updated: January 20, 2025

Investigational Drug Information for Darinaparsin


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What is the drug development status for Darinaparsin?

Darinaparsin is an investigational drug.

There have been 12 clinical trials for Darinaparsin. The most recent clinical trial was a Phase 2 trial, which was initiated on March 25th 2016.

The most common disease conditions in clinical trials are Lymphoma, Lymphoma, T-Cell, Peripheral, and Lymphoma, T-Cell. The leading clinical trial sponsors are Ziopharm, Solasia Pharma K.K., and Synex Consulting Korea Ltd.

There are thirty-four US patents protecting this investigational drug and four hundred and thirty-one international patents.

Recent Clinical Trials for Darinaparsin
TitleSponsorPhase
A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)Solasia Pharma K.K.Phase 2
A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL) in KoreaSynex Consulting Korea Ltd.Phase 1
A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL) in KoreaSolasia Pharma K.K.Phase 1

See all Darinaparsin clinical trials

Clinical Trial Summary for Darinaparsin

Top disease conditions for Darinaparsin
trials01122334455667LymphomaLymphoma, T-Cell, PeripheralLymphoma, T-CellNeoplasms[disabled in preview]
Top clinical trial sponsors for Darinaparsin
trials0123456789ZiopharmSolasia Pharma K.K.Synex Consulting Korea Ltd.[disabled in preview]

See all Darinaparsin clinical trials

US Patents for Darinaparsin

DrugnamePatent NumberPatent TitlePatent AssigneeEstimated Expiration
Darinaparsin ⤷  Subscribe Anti-CS1 antibodies and antibody drug conjugates AbbVie Biotherapeutics Inc. (Redwood City, CA) ⤷  Subscribe
Darinaparsin ⤷  Subscribe Controlled release dosage form TRIASTEK, INC. (Nanjing, CN) ⤷  Subscribe
Darinaparsin ⤷  Subscribe Modified macrocyclic compounds BAYER PHARMA AKTIENGESELLSCHAFT (Berlin, DE) ⤷  Subscribe
Darinaparsin ⤷  Subscribe Anti-CS1 antibodies and antibody drug conjugates AbbVie Biotherapeutics Inc. (Redwood City, CA) ⤷  Subscribe
Darinaparsin ⤷  Subscribe ASH1L inhibitors and methods of treatment therewith The Regents of the University of Michigan (Ann Arbor, MI) ⤷  Subscribe
Darinaparsin ⤷  Subscribe AZO-substituted pyridine and pyrimidine derivatives and their use in treating viral infections Merck Sharp & Dohme Corp. (Rahway, NJ) Southern Research Institute (Birmingham, AL) ⤷  Subscribe
>Drugname>Patent Number>Patent Title>Patent Assignee>Estimated Expiration
Showing 1 to 6 of 6 entries

International Patents for Darinaparsin

DrugnameCountryDocument NumberEstimated ExpirationRelated US Patent
Darinaparsin Australia AU2015339012 2034-10-31 ⤷  Subscribe
Darinaparsin Brazil BR112017008945 2034-10-31 ⤷  Subscribe
Darinaparsin Canada CA2966005 2034-10-31 ⤷  Subscribe
Darinaparsin European Patent Office EP3212668 2034-10-31 ⤷  Subscribe
Darinaparsin Japan JP2017537893 2034-10-31 ⤷  Subscribe
Darinaparsin Spain ES2832711 2034-10-31 ⤷  Subscribe
>Drugname>Country>Document Number>Estimated Expiration>Related US Patent
Showing 1 to 6 of 6 entries

Darinaparsin: A Promising Treatment for Relapsed or Refractory Peripheral T-Cell Lymphoma

Introduction

Darinaparsin, a novel organic arsenical compound, has emerged as a significant treatment option for relapsed or refractory peripheral T-cell lymphoma (PTCL), a type of malignant lymphoma with limited treatment options. Here, we delve into the development updates, clinical trial results, and market projections for this promising drug candidate.

Mechanism of Action

Darinaparsin works by disrupting mitochondrial function, increasing the production of reactive oxygen species, and modulating intracellular signal transduction pathways. This mechanism leads to cell cycle arrest and apoptosis, making it an effective anticancer agent[1][3][5].

Clinical Trials and Efficacy

Phase 2 Clinical Trials

In a global phase 2 pivotal study conducted in Asian patients with relapsed or refractory PTCL, darinaparsin demonstrated an overall response rate (ORR) of 19.3% (90% confidence interval: 11.2-29.9%). This included complete responses (CR) in 8.8% of patients and partial responses (PR) in 10.5%. The disease control rate (DCR) was 45.6%, indicating a significant antitumor effect[2][3].

Adverse Events

While treatment-emergent adverse events (TEAEs) were common, with 98.5% of patients experiencing some form of TEAE, grade ≥3 TEAEs were manageable. The most frequent grade ≥3 TEAEs included anemia, thrombocytopenia, neutropenia, leukopenia, lymphopenia, and hypertension[2][3].

Regulatory Approvals

Japan

In June 2022, Solasia Pharma K.K. received approval for darinaparsin from the Ministry of Health, Labour and Welfare (MHLW) in Japan for the treatment of relapsed or refractory PTCL. Nippon Kayaku Co., Ltd. launched the drug in August 2022 under the brand name DARVIAS®[1][4][5].

Other Regions

  • South Korea, Taiwan, Hong Kong: Phase II pivotal studies have been completed, and out-licensing activities are ongoing. Preparations to file for approval are underway based on the Japanese approval[1].
  • South America: Preparations to file for approval are in progress in each country, leveraging the approval granted in Japan. Colombia has already filed for approval[1].
  • China: A development strategy is being drafted based on US study data and the Japanese approval. Out-licensing activities are ongoing[1].
  • US and EU: Early phase II studies have been completed, and out-licensing activities are in progress. In the EU, a New Product Procedure (NPP) strategy is being launched[1].

Market Projection

Unmet Medical Need

PTCL is a disease with high unmet medical needs due to its aggressive nature and poor response to conventional therapies. The lack of a standard treatment for relapsed or refractory PTCL makes darinaparsin a highly anticipated addition to the therapeutic arsenal[1][4].

Market Potential

Given the approval in Japan and the ongoing regulatory processes in other regions, darinaparsin is poised to capture a significant share of the market for PTCL treatments. The drug's unique mechanism of action and its ability to induce apoptosis and cell cycle arrest in tumor cells make it a competitive option in the oncology market.

Partnership and Licensing

The license agreement between Solasia Pharma K.K. and Nippon Kayaku Co., Ltd. in Japan is a strategic move to leverage Nippon Kayaku's extensive experience in oncology and its strong sales network. Similar partnerships in other regions could further enhance the drug's market reach and penetration[4].

Expected Target Indications

Peripheral T-Cell Lymphoma (PTCL)

PTCL is the primary target indication for darinaparsin. This subtype of T-cell lymphoma has a relatively high incidence rate and lacks a standard treatment, making darinaparsin a critical new option for patients and healthcare providers[1][3].

Future Development

Additional Indications

Solasia is exploring additional indications for darinaparsin beyond PTCL, including other hematologic and solid tumors. The drug's mechanism of action suggests potential efficacy in various cancer types, which could expand its market scope in the future[1].

Key Takeaways

  • Mechanism of Action: Darinaparsin disrupts mitochondrial function, increases reactive oxygen species, and modulates signal transduction pathways.
  • Clinical Trials: Phase 2 trials showed an ORR of 19.3% and a DCR of 45.6% in PTCL patients.
  • Regulatory Approvals: Approved in Japan in June 2022; ongoing regulatory processes in other regions.
  • Market Potential: High unmet medical need in PTCL treatment; strategic partnerships to enhance market reach.
  • Future Development: Exploring additional indications beyond PTCL.

FAQs

What is darinaparsin and how does it work?

Darinaparsin is a novel organic arsenical compound that works by disrupting mitochondrial function, increasing reactive oxygen species, and modulating intracellular signal transduction pathways, leading to cell cycle arrest and apoptosis.

What is the current regulatory status of darinaparsin?

Darinaparsin has been approved in Japan for the treatment of relapsed or refractory PTCL and is in various stages of regulatory review in other regions, including South Korea, Taiwan, Hong Kong, South America, China, the US, and the EU.

What are the common adverse events associated with darinaparsin?

Common adverse events include anemia, thrombocytopenia, neutropenia, leukopenia, lymphopenia, and hypertension, most of which are grade ≥3 and manageable.

What is the market potential for darinaparsin?

Given the high unmet medical need in PTCL treatment and the drug's unique mechanism of action, darinaparsin has significant market potential, especially with strategic partnerships to enhance its reach.

Is darinaparsin being explored for other indications?

Yes, Solasia is exploring additional indications for darinaparsin beyond PTCL, including other hematologic and solid tumors.

Sources

  1. Solasia Pharma K.K. - DARVIAS® (SP-02) - Pipeline Information.
  2. Blood Advances - Darinaparsin in patients with relapsed or refractory peripheral T-cell lymphoma.
  3. PubMed - Pharmacological profile and clinical study results of darinaparsin.
  4. Via TT - Solasia and Nippon Kayaku Announce License Agreement in Japan for New Drug Candidate DARINAPARSIN (SP-02).
  5. MDPI - Cytotoxic Effects of Darinaparsin, a Novel Organic Arsenical, against Malignant Cell Lines.

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