Herald Therapeutics Receives Fifth Global Patent
The United States Patent and Trademark Office (USPTO) grant extends ThyrOxy intellectual property estate to five issued global patents and protects a novel clinical dosing methodology developed by Herald’s scientific co-founders. The new claims protect direct-to-lung T3 administration with serum-guided dose titration in ARDS.
MINNEAPOLIS, MN – Herald Therapeutics, Inc., a clinical-stage biopharmaceutical company developing the ThyrOxy thyroid hormone–based therapeutic platform for life-threatening lung and heart diseases, today announced that the U.S. Patent and Trademark Office (USPTO) has issued U.S. Patent No. 12,569,459, titled “Compositions and Methods for Treating Pulmonary Edema or Lung Inflammation,” extending intellectual property protection over Herald’s lead asset. The newly issued patent is the third U.S. patent covering ThyrOxy and was prosecuted by the University of Minnesota, Herald’s exclusive licensor. The patent issued on March 10, 2026, with a term extending into the early 2040s after accounting for patent term adjustment.
The newly granted patent claims novel methods of treating Acute Respiratory Distress Syndrome (ARDS) through direct sinopulmonary administration of tri-iodothyronine (T3) guided by serum-T3 monitoring and dose titration. The protected methodology pairs a lung-safe pharmaceutical composition of T3 with a clinical dose-escalation protocol in which serum T3 is measured before and during treatment and the dose is adjusted to bring the patient’s serum T3 into, or maintain it within, the established normal range. This approach is designed to deliver T3 where it is therapeutically active in the injured lung while limiting unwanted systemic exposure.
The patent’s named inventors are Herald’s three scientific and clinical co-founders: David H. Ingbar, MD, Chief Scientific Officer; Timothy P. Rich, MD, Chief Medical Officer; and Robert J. Schumacher, PhD, Chief Research & Development Officer. The patent reflects more than three decades of foundational research at the University of Minnesota into the role of thyroid hormone in lung biology, alveolar fluid clearance, and recovery from acute lung injury.
A Deliberate, Multi-Layered Patent Strategy
With this grant, Herald’s global patent estate now includes five issued patents covering ThyrOxy across a layered framework of composition, formulation, methods of treatment, and dose-titration claims, with additional U.S. and international applications pending. Together, these claims are designed to provide robust, multi-tiered commercial exclusivity across Herald’s lead indications — Acute Respiratory Distress Syndrome (ARDS), Infant Respiratory Distress Syndrome (IRDS), and Acute Heart Failure — and to support extension of the platform into the broader continuum of fibrotic lung disease.
“This fifth patent meaningfully strengthens what is already a deliberate, multi-layered estate around the ThyrOxy platform,” said Wade A. Smith, Chief Executive Officer of Herald Therapeutics. “What is particularly distinctive about U.S. Patent No. 12,569,459 is that it protects not only the composition and route of administration, but the clinical methodology by which a treating physician would optimize dosing in real time — a level of protection that is intentionally difficult to design around. We are deeply appreciative of the University of Minnesota’s technology commercialization team, whose continued partnership has been instrumental in prosecuting and protecting these foundational claims.”
“This approach to treating ARDS was triggered by two key discoveries: that thyroid hormone stimulates alveolar absorption of pulmonary edema fluid and that ARDS lungs have marked reduction in the amount of thyroid hormones,“ said David H. Ingbar, MD, Co-Founder and Chief Scientific Officer of Herald Therapeutics and a named inventor on the patent. “Direct delivery of T3 to the alveoli via airspace instillation, and titrating it to the patient’s own serum response, is fundamentally different from systemic dosing. This patent protects that strategy on the strength of preclinical and first-in-human evidence accumulated over many years of careful work.”
Addressing a High-Mortality Condition with No Approved Therapy
ARDS remains a high-mortality condition with no approved disease-modifying therapy and a long- standing area of significant unmet need in critical care medicine. Herald’s scientific co-founders previously reported the first-in-human instillation of thyroid hormone into the lungs of a patient with ARDS, work that informed the methodology now protected by the issued patent. The company is advancing ThyrOxy toward pivotal clinical development in ARDS, with platform extension into IRDS and acute heart failure under active scientific evaluation.
About ThyrOxy
ThyrOxy™ is Herald Therapeutics’ proprietary thyroid hormone–based therapeutic platform, designed to address the fundamental biology of acute lung injury. In addition to its lead indication in ARDS, ThyrOxy is being advanced in Infant Respiratory Distress Syndrome (IRDS) and Acute Heart Failure. ThyrOxy was originally developed at the University of Minnesota and is exclusively licensed to Herald Therapeutics.
About Herald Therapeutics
Herald Therapeutics, Inc. is a clinical-stage biopharmaceutical company headquartered in Minneapolis, Minnesota, developing ThyrOxy, a thyroid hormone–based therapeutic platform targeting life-threatening lung and cardiac diseases. The company’s lead programs are in Acute Respiratory Distress Syndrome (ARDS), Infant Respiratory Distress Syndrome (IRDS), and Acute Heart Failure. For more information, please visit heraldtx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the scope, duration, and enforceability of Herald’s patent estate; the therapeutic potential of ThyrOxy in ARDS, IRDS, acute heart failure, and other indications; and the Company’s broader development plans. Forward-looking statements are subject to known and unknown risks and uncertainties, many of which are beyond the Company’s control—including the risk that clinical trials may not produce the expected results, that patent protections may be challenged or narrowed, and that regulatory approvals may not be obtained. Actual results may differ materially from those expressed or implied. Herald Therapeutics undertakes no obligation to update any forward-looking statements except as required by law.
Investor & Media Contact
Wade A. Smith, CEO
Herald Therapeutics, Inc.
wsmith@heraldtx.com | 412-216-9988