FDA grants Fast Track designation to 4TEEN4’s invobenitug for cardiogenic shock

Edited by Robert McTiernan··2 min read

4TEEN4 Pharmaceuticals GmbH, headquartered in Germany, announced receipt of US FDA Fast Track Designation for invobenitug (formerly procizumab), a monoclonal antibody in development for cardiogenic shock. The designation is the company’s first major regulatory milestone for the molecule, which is still in early clinical testing and has no approved comparator targeting its specific biological pathway.

Invobenitug is a humanized antibody that neutralizes circulating dipeptidyl peptidase 3 (cDPP3), an enzyme that leaks into the bloodstream after cellular injury and degrades angiotensin II, disrupting the renin-angiotensin-aldosterone system. That disruption is thought to contribute to the circulatory collapse and organ failure characteristic of cardiogenic shock. By blocking cDPP3, invobenitug is intended to restore this signaling axis and stabilize cardiovascular function in patients with elevated cDPP3 concentrations, a biomarker-selected subgroup.

The Fast Track application drew on a completed Phase I study in healthy volunteers, in which single ascending doses of 3 mg/kg to 12 mg/kg produced no serious adverse events and showed dose-dependent inhibition of cDPP3 activity, according to findings published in mAbs. Separately, three compassionate-use cases in patients with cardiogenic shock and multi-organ failure showed reversal of shock within 48 hours of a single 10 mg/kg infusion, with no drug-related adverse events reported. Those results, while uncontrolled and limited to three patients, provided the first human efficacy signal supporting the molecule’s mechanism. The drug is now being tested more formally in PROCARD 2a (NCT06832722), a randomized, placebo-controlled Phase Ib/IIa trial enrolling up to 70 patients with cardiogenic shock and elevated cDPP3 across 11 European centers, assessing safety, pharmacokinetics, and exploratory efficacy.

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Fast Track status gives 4TEEN4 more frequent access to FDA reviewers during development and potential eligibility for rolling review of a future marketing application, but it does not alter the current data requirements for PROCARD 2a or any subsequent pivotal trial. Cardiogenic shock carries mortality exceeding 50%, and no approved pharmacologic therapy currently targets its underlying molecular drivers, meaning invobenitug would be entering a market largely defined by supportive care rather than competing biologics. That absence of a direct competitor makes the designation notable less for accelerating a race against rivals than for validating cDPP3 as a drug target in a disease category regulators have historically been reluctant to expedite.

The company financed this stage of work through a Series C round extended to EUR 55 million in November 2025, earmarked partly for expanding PROCARD 2a into the US. 4TEEN4 has said interim pharmacokinetic and safety data from the trial are expected in early 2026, with a global pivotal Phase II/III study planned to follow. Those readouts, rather than the Fast Track designation itself, will determine whether invobenitug advances toward a registration pathway for cardiogenic shock.

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