FDA Events for Conduit Pharmaceuticals (CDT)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Conduit Pharmaceuticals (CDT).
Over the past two years, Conduit Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AZD1656. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
AZD1656 - FDA Regulatory Timeline and Events
AZD1656 is a drug developed by Conduit Pharmaceuticals for the following indication: For Lupus Erythematosus model.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AZD1656
- Announced Date:
- June 4, 2025
- Indication:
- For Lupus Erythematosus model.
Announcement
Conduit Pharmaceuticals Inc announced that it has entered into a joint development agreement with Manoira Corporation ("Manoira"), a privately held specialty animal health company specializing in proprietary reformulation technologies to create novel therapeutics for veterinary and livestock applications. Under the terms of the joint development agreement, Manoira will evaluate Conduit's AZD1656 and AZD5658, both clinical-stage glucokinase activators, in animal health indications, providing Conduit with high-value translational data across human and veterinary applications.
AI Summary
Conduit Pharmaceuticals Inc. has entered a joint development agreement with Manoira Corporation, a specialty animal health company known for its proprietary reformulation technologies. Under this agreement, Manoira will evaluate Conduit’s clinical-stage drugs, AZD1656 and AZD5658, for veterinary applications. The initial focus is on assessing AZD1656 for treating osteoarthritis in companion animals, which will provide valuable preclinical data to support Conduit’s human clinical programs. Additionally, Manoira will explore the potential of AZD5658 and test a novel combination therapy involving its patented CBDA co-crystal. This collaboration aims to generate high-value translational insights across human and animal health, while Conduit retains 100% ownership of all related data and intellectual property. By leveraging Manoira’s expertise in animal health, the agreement supports a cost-efficient approach that advances drug development and opens access to the growing $15 billion animal health market.
Read Announcement - Drug:
- AZD1656
- Announced Date:
- March 31, 2025
- Indication:
- For Lupus Erythematosus model.
Announcement
Conduit Pharmaceuticals Inc announces that the United States Patent and Trademark Office (USPTO) has granted the composition of matter patent for its lead asset, AZD1656, a Glucokinase Activator targeting autoimmune diseases, including Lupus and ANCA Vasculitis. With this critical composition of matter patent protection now secured, the Company is strategically positioned to advance AZD1656 into clinical development, with clinical trial plans now in final stages of preparation.
AI Summary
Conduit Pharmaceuticals has secured a crucial composition of matter patent from the USPTO for its lead asset, AZD1656. This patented Glucokinase Activator targets autoimmune diseases such as Lupus and ANCA Vasculitis. With this key intellectual property now firmly in place, the company is well-positioned to move AZD1656 into clinical development. Clinical trial plans are currently in the final stages of preparation, setting the stage for advancing this potential treatment through the drug development process.
The patent protection not only strengthens Conduit’s position in the U.S. market but also opens up opportunities for strategic partnerships and commercial licensing. This milestone is a significant step forward in the company’s efforts to address the growing need for innovative treatments within the expansive U.S. autoimmune disease market.
Read Announcement- Drug:
- AZD1656
- Announced Date:
- March 19, 2025
- Indication:
- For Lupus Erythematosus model.
Announcement
Conduit Pharmaceuticals Inc today provides an R&D update on the development progress of pipeline assets AZD1656, AZD5658, and AZD5904.
AI Summary
Conduit Pharmaceuticals has shared an R&D update on its key pipeline assets: AZD1656, AZD5658, and AZD5904. The company is making solid progress by advancing preclinical studies for AZD5658, where it is evaluating a glucokinase inhibitor in a lupus model to determine its effects on disease progression and immune regulation. In parallel, Conduit is refining the design of a Phase IIa trial for AZD1656, which will assess the drug’s safety and effectiveness in patients with systemic lupus erythematosus and ANCA-associated vasculitis.
Additionally, the company is focused on optimizing the formulation of its pipeline assets while expanding its intellectual property portfolio. These initiatives are designed to boost the clinical development prospects of its drugs and position the company for near-term milestones, paving the way for future growth and potential commercialization of its therapies.
Read Announcement- Drug:
- AZD1656
- Announced Date:
- February 13, 2025
- Indication:
- For Lupus Erythematosus model.
Announcement
Conduit Pharmaceuticals Inc. announce an agreement with Charles River Laboratories Inc ("Charles River") to evaluate AZD1656 (and its derivatives) in a clinically relevant Systemic Lupus Erythematosus model.
AI Summary
Conduit Pharmaceuticals has partnered with Charles River Laboratories to evaluate its lead compound, AZD1656 (and its derivatives), using a clinically relevant Systemic Lupus Erythematosus (SLE) model. The goal is to gather robust preclinical data that will help refine study parameters through Charles River’s immunology expertise. This collaboration is designed to accelerate AZD1656’s development for autoimmune disorders, particularly SLE and Lupus Nephritis. By closely analyzing the drug's effect on disease progression, inflammatory markers, and cytokine levels, Conduit aims to enhance its understanding of the treatment’s potential impact. The high-quality data generated from this study is expected to de-risk and improve the design of upcoming Phase II clinical trials, ultimately increasing the likelihood of successful outcomes and positioning AZD1656 as a promising candidate for future therapies in autoimmune conditions.
Read Announcement
Conduit Pharmaceuticals FDA Events - Frequently Asked Questions
As of now, Conduit Pharmaceuticals (CDT) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Conduit Pharmaceuticals (CDT) has reported FDA regulatory activity for AZD1656.
The most recent FDA-related event for Conduit Pharmaceuticals occurred on June 4, 2025, involving AZD1656. The update was categorized as "Provided Update," with the company reporting: "Conduit Pharmaceuticals Inc announced that it has entered into a joint development agreement with Manoira Corporation ("Manoira"), a privately held specialty animal health company specializing in proprietary reformulation technologies to create novel therapeutics for veterinary and livestock applications. Under the terms of the joint development agreement, Manoira will evaluate Conduit's AZD1656 and AZD5658, both clinical-stage glucokinase activators, in animal health indications, providing Conduit with high-value translational data across human and veterinary applications."
Currently, Conduit Pharmaceuticals has one therapy (AZD1656) targeting the following condition: For Lupus Erythematosus model..
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:CDT) was last updated on 7/14/2025 by MarketBeat.com Staff
