CAD-1005
An investigational treatment for Heparin-Induced Thrombocytopenia.
The same compound appears under different names depending on the context. Here is how to identify CAD-1005 wherever you encounter it, plus the key facts at a glance.
- Generic name
- CAD-1005
- Development codes
- CAD-1005, VLX-1005
- Drug class
- 12-LOX inhibitor
- Manufacturer
- Cadrenal Therapeutics
- How it's taken
- In the planned Phase 3 trial, hospitalized patients with suspected HIT will receive CAD-1005 (or placebo) on top of standard anticoagulant therapy for up to 14 days.
An investigational IV drug for heparin-induced thrombocytopenia (HIT). Unlike current options that only manage clotting, CAD-1005 targets the platelet activation that drives HIT.
How CAD-1005 works
In HIT, the body makes antibodies against heparin that mistakenly turn on platelets, triggering a cycle of dangerous clotting. CAD-1005 blocks an enzyme called 12-LOX (12-lipoxygenase) that platelets use to amplify this activation. By turning down that signal, the drug aims to interrupt the clotting cycle at its source, rather than just preventing new clots downstream like today's HIT therapies do.
Mechanism: First-in-class small-molecule inhibitor of 12-lipoxygenase (12-LOX), the enzyme that drives platelet activation in HIT
Side effects and safety
Detailed safety data have not been published. In the planned Phase 3 trial, major bleeding is a key safety measure, since CAD-1005 would be given on top of anticoagulants.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking CAD-1005
In the planned Phase 3 trial, hospitalized patients with suspected HIT will receive CAD-1005 (or placebo) on top of standard anticoagulant therapy for up to 14 days. Final route, dose, and frequency for any future approval will follow Phase 3 results.
Clinical trial results
On April 30, 2026, Cadrenal completed its End-of-Phase 2 meeting with the FDA and received guidance for a single pivotal Phase 3 study: randomized, blinded and placebo-controlled, in about 120 patients at up to 50 sites. After a further FDA meeting, Cadrenal said in August 2026 that the main measure will be new or worsening clotting events through Day 14 or hospital discharge in lab-confirmed HIT, with CAD-1005 or placebo added to standard anticoagulation. In August 2026, Cadrenal also said it is seeking a partner for CAD-1005 and does not plan to fund large late-stage trials alone, so the Phase 3 start depends on a partner or funding.
Development history
CAD-1005 was originally known as VLX-1005. Cadrenal Therapeutics acquired it from Veralox Therapeutics. The drug has Orphan Drug and Fast Track designations from the U.S. FDA, plus orphan status from the European Medicines Agency. Cadrenal describes it as a potential first new HIT therapy in more than two decades.
Explore Heparin-Induced Thrombocytopenia trials
Common questions about CAD-1005
▸What is CAD-1005?
An investigational IV drug for heparin-induced thrombocytopenia (HIT). Unlike current options that only manage clotting, CAD-1005 targets the platelet activation that drives HIT.
▸How does CAD-1005 work?
In HIT, the body makes antibodies against heparin that mistakenly turn on platelets, triggering a cycle of dangerous clotting. CAD-1005 blocks an enzyme called 12-LOX (12-lipoxygenase) that platelets use to amplify this activation. By turning down that signal, the drug aims to interrupt the clotting cycle at its source, rather than just preventing new clots downstream like today's HIT therapies do.
▸What are the side effects of CAD-1005?
Detailed safety data have not been published. In the planned Phase 3 trial, major bleeding is a key safety measure, since CAD-1005 would be given on top of anticoagulants.
▸How is CAD-1005 taken?
In the planned Phase 3 trial, hospitalized patients with suspected HIT will receive CAD-1005 (or placebo) on top of standard anticoagulant therapy for up to 14 days. Final route, dose, and frequency for any future approval will follow Phase 3 results.
▸Is CAD-1005 FDA approved?
CAD-1005 is currently in phase 2 clinical trials for Heparin-Induced Thrombocytopenia. It has not yet received FDA approval.
▸What is HIT and why is a new drug needed?
HIT is an immune reaction to heparin in which antibodies activate platelets and cause dangerous clots. Today's options (argatroban, bivalirudin, fondaparinux) prevent additional clots but don't address the platelet activation driving the reaction. Cadrenal is developing CAD-1005 to target that process.
▸How is CAD-1005 different from existing HIT treatments?
Current treatments are anticoagulants — they slow new clots from forming. CAD-1005 instead blocks the 12-LOX enzyme inside platelets, which the immune-mediated HIT process uses to keep activating more platelets. The goal is to break the cycle at its source.
▸When could CAD-1005 be available?
It's still investigational. The Phase 3 trial has not started; in August 2026 Cadrenal said it is looking for a partner to fund late-stage development. Cadrenal has projected an FDA submission in 2029, which depends on the Phase 3 trial going ahead.
▸Has CAD-1005 received any FDA designations?
Yes. CAD-1005 has received both Orphan Drug Designation and Fast Track designation from the FDA, and orphan drug status from the European Medicines Agency. These designations recognize the seriousness of HIT and the lack of alternative treatments targeting the immune mechanism.
▸How would patients enroll in the Phase 3 trial?
The Phase 3 trial will enroll hospitalized patients with suspected HIT across up to 50 sites worldwide. Site-specific enrollment details will be posted on ClinicalTrials.gov once the trial begins. Patients and families should ask the treating hematologist whether participation is appropriate.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- Cadrenal Therapeutics · 2026-04-30. Cadrenal Therapeutics Announces End-of-Phase 2 Meeting with the FDA and Pivotal Phase 3 Registration Path for CAD-1005. https://www.cadrenal.com/cadrenal-therapeutics-announces-end-of-phase-2-meeting-with-the-fda-and-pivotal-phase-3-registration-path-for-cad-1005-in-heparin-induced-thrombocytopenia-hit/
- Cadrenal Therapeutics · 2026-08-31. Cadrenal Therapeutics Announces Positive Outcome from FDA Type D Meeting for Phase 3 Registration Study of CAD-1005. https://www.globenewswire.com/news-release/2026/08/31/3353254/0/en/cadrenal-therapeutics-announces-positive-outcome-from-fda-type-d-meeting-for-phase-3-registration-study-of-cad-1005-in-heparin-induced-thrombocytopenia.html
- Cadrenal Therapeutics / SEC · 2026-08-13. Cadrenal Q2 2026 results, 8-K Exhibit 99.1. https://www.sec.gov/Archives/edgar/data/1937993/000121390026089147/ea030204201ex99-1.htm