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Last Updated: July 18, 2025

Investigational Drug Information for Ladarixin


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What is the drug development status for Ladarixin?

Ladarixin is an investigational drug.

There have been 8 clinical trials for Ladarixin. The most recent clinical trial was a Phase 2 trial, which was initiated on December 21st 2020.

The most common disease conditions in clinical trials are Diabetes Mellitus, Type 1, Diabetes Mellitus, and Lung Neoplasms. The leading clinical trial sponsors are Dompé Farmaceutici S.p.A, NYU Langone Health, and [disabled in preview].

There are nine US patents protecting this investigational drug and seventy-nine international patents.

Recent Clinical Trials for Ladarixin
TitleSponsorPhase
Ladarixin With Sotorasib in Advanced NSCLC - Phase IINYU Langone HealthPhase 2
Ladarixin With Sotorasib in Advanced NSCLC - Phase INYU Langone HealthPhase 1
Randomized, Double-blind, Clinical Trial on Ladarixin Adjunctive Therapy to Improve Glycemic Control in Type 1 Diabetes.Dompé Farmaceutici S.p.APhase 2

See all Ladarixin clinical trials

Clinical Trial Summary for Ladarixin

Top disease conditions for Ladarixin
Top clinical trial sponsors for Ladarixin

See all Ladarixin clinical trials

US Patents for Ladarixin

Drugname Patent Number Patent Title Patent Assignee Estimated Expiration
Ladarixin ⤷  Try for Free Oral drug dosage forms having desired drug release profiles and uses thereof Triastek, Inc. (Nanjing, CN) ⤷  Try for Free
Ladarixin ⤷  Try for Free Soluble C5aR antagonists ChemoCentryx, Inc. (Mountain View, CA) ⤷  Try for Free
Ladarixin ⤷  Try for Free Compartmented pharmaceutical dosage forms Triastek, Inc. (Nanjing, CN) ⤷  Try for Free
Ladarixin ⤷  Try for Free Soluble C5aR antagonists ChemoCentryx, Inc. (Mountain View, CA) ⤷  Try for Free
Ladarixin ⤷  Try for Free Method for treating cancer using dual antagonists of CXCR1 and CXCR2 Syntrix Biosystems Inc. (Auburn, WA) ⤷  Try for Free
>Drugname >Patent Number >Patent Title >Patent Assignee >Estimated Expiration

International Patents for Ladarixin

Drugname Country Document Number Estimated Expiration Related US Patent
Ladarixin Australia AU2016272089 2035-06-03 ⤷  Try for Free
Ladarixin Canada CA2987114 2035-06-03 ⤷  Try for Free
Ladarixin China CN106236715 2035-06-03 ⤷  Try for Free
Ladarixin China CN108653221 2035-06-03 ⤷  Try for Free
Ladarixin China CN108721242 2035-06-03 ⤷  Try for Free
>Drugname >Country >Document Number >Estimated Expiration >Related US Patent

Ladarixin: A Promising Drug Candidate for Type 1 Diabetes

Last updated: January 2, 2025

Introduction to Ladarixin

Ladarixin, developed by Dompé, is an investigational small-molecule drug that has garnered significant attention for its potential in treating type 1 diabetes. This autoimmune disease, characterized by the immune system's attack on pancreatic beta cells, affects millions worldwide, including an estimated 1.84 million Americans[1][3].

Mechanism of Action

Ladarixin operates as a non-competitive, dual allosteric inhibitor of CXCL8 (IL-8) receptors, specifically targeting CXCR1 and CXCR2. The hypothesis behind its development is that by inhibiting these receptors, Ladarixin can prevent inflammation and the destruction of beta cells in pancreatic islets, thereby delaying disease progression and improving metabolic control[1][3].

Clinical Trials and Development

Phase 1 and Phase 2 Trials

Ladarixin has successfully completed Phase 1 and Phase 2 clinical trials. The results from these trials were presented at the 2020 virtual American Diabetes Association’s Scientific Sessions and published in the June 2020 edition of Diabetes. These studies demonstrated the drug's safety and efficacy, paving the way for further research[1][3].

Ongoing Phase 3 Trials

Currently, Ladarixin is in Phase 3 clinical trials, specifically in a randomized, multicenter, double-blind, placebo-controlled study. This trial aims to assess the efficacy and safety of Ladarixin in adolescents and adults with new-onset type 1 diabetes. The primary goal is to evaluate the drug's ability to preserve beta cell function by inhibiting the biological activity of IL-8[1][3].

Additional Phase 2 Studies

In addition to the Phase 3 trial, another ongoing Phase 2 study is investigating Ladarixin as an adjunctive therapy to improve glycemic control in overweight, insulin-resistant adults with type 1 diabetes. This study is also randomized, multicenter, double-blind, and placebo-controlled[1][3].

Collaborative Research and Development

The development of Ladarixin is a result of collaborative efforts between Dompé and numerous research partners and diabetic experts worldwide. This collaboration has been instrumental in advancing the drug through various stages of clinical trials[1][3].

Tolerability and Safety

Ladarixin has shown high tolerability with no toxic secondary effects, making it a promising candidate for long-term treatment. Its availability as oral capsules further enhances its potential for patient compliance[1][3].

Effects on Insulin Resistance and Inflammation

Studies have shown that Ladarixin can ameliorate insulin resistance by inhibiting inflammation and improving insulin signaling. For instance, in a study involving 3T3-L1 adipocytes, Ladarixin treatment reduced the activation of inflammatory signals and improved glucose transport and insulin response[2].

Market Projections

Growing Demand for Novel Therapies

The type 1 diabetes market is expected to grow significantly over the next decade, driven by the increasing prevalence of the disease and the development of novel drugs and therapies. According to DelveInsight, the market is anticipated to grow at a substantial CAGR from 2019 to 2032[5].

Competitive Landscape

Ladarixin is part of a broader landscape of emerging therapies for type 1 diabetes. Key players in this market include Eli Lilly, Vertex, Bayer, Novo Nordisk, and others. The inclusion of Ladarixin in this competitive landscape highlights its potential to become a significant player in the treatment of type 1 diabetes[5].

Key Takeaways

  • Mechanism of Action: Ladarixin inhibits CXCL8 (IL-8) receptors, specifically CXCR1 and CXCR2, to prevent inflammation and beta cell destruction.
  • Clinical Trials: Ladarixin is in Phase 3 trials for new-onset type 1 diabetes and in additional Phase 2 studies for improving glycemic control.
  • Collaborative Efforts: Developed through collaborations with global research partners and diabetic experts.
  • Tolerability and Safety: High tolerability with no toxic secondary effects.
  • Market Potential: Part of a growing market for novel type 1 diabetes therapies, expected to expand significantly by 2032.

FAQs

What is Ladarixin?

Ladarixin is an investigational small-molecule drug developed by Dompé to treat type 1 diabetes by inhibiting IL-8 receptors.

What is the current stage of Ladarixin in clinical trials?

Ladarixin is currently in Phase 3 clinical trials for new-onset type 1 diabetes and in additional Phase 2 studies.

How does Ladarixin work?

Ladarixin works by inhibiting CXCL8 (IL-8) receptors, specifically CXCR1 and CXCR2, to prevent inflammation and the destruction of beta cells in pancreatic islets.

What are the potential benefits of Ladarixin?

Ladarixin has the potential to delay disease progression, improve metabolic control, and enhance glycemic control in type 1 diabetes patients.

Is Ladarixin safe and tolerable?

Yes, Ladarixin has shown high tolerability with no toxic secondary effects in clinical trials.

What is the market outlook for Ladarixin?

The type 1 diabetes market, which includes Ladarixin, is expected to grow significantly over the next decade due to the increasing prevalence of the disease and the development of novel therapies.

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