Cadrenal Therapeutics disclosed early Phase 2 data for its first selective 12‑lipoxygenase (12‑LOX) inhibitor, VLX‑1005, in patients with suspected heparin‑induced thrombocytopenia (HIT). The study, identified as VLX‑1005‑003, enrolled a small cohort of high‑risk patients and showed a reduction in thrombotic complications compared with historical controls, indicating that the drug’s immune‑targeted mechanism may translate into a safer anticoagulant profile.
VLX‑1005 is the first‑in‑class 12‑LOX inhibitor that blocks the immune‑driven platelet activation that underlies HIT. The compound has received Orphan Drug Designation and Fast Track status from the FDA, as well as orphan status from the EMA, positioning it for a streamlined regulatory pathway and a seven‑year exclusivity period that can support premium pricing.
The HIT sub‑segment of the anticoagulation market is estimated at $1 billion in the United States and European Union, while the broader anticoagulation market is valued at $40 billion. By targeting a niche with high unmet need, Cadrenal’s strategy to focus on orphan indications aligns with its broader pipeline of high‑risk anticoagulants, such as tecarfarin and frunexian.
Cadrenal acquired VLX‑1005 in December 2025, adding the compound to its orphan‑drug portfolio and creating a potential new revenue stream in a high‑risk niche. CEO Quang X. Pham said, “HIT remains a life‑threatening condition with a strikingly high risk of thrombosis despite available therapies. By selectively targeting 12‑LOX, VLX‑1005 has the potential to address a core disease mechanism in HIT.”
Investors reacted positively to the announcement, citing the early clinical signals, the strategic acquisition, and the regulatory designations as key drivers of confidence in Cadrenal’s pipeline.
Cadrenal plans to discuss a pivotal Phase 3 study with the FDA and is preparing for regulatory submission, aiming to bring the first FDA‑approved treatment for HIT to market and to strengthen its position in the high‑risk anticoagulation niche.
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