Intellectual Property

Strong IP Protection for a Platform Technology

Amalgent's approach to safer opioid therapy is protected by a comprehensive patent portfolio covering mechanisms, compositions, and treatment methods that reduce tolerance and dependence while preserving pain relief.

Three Issued U.S. Patents

U.S. Patent No. 11,202,777 (December 21, 2021)
Methods for maintaining opioid efficacy while reducing tolerance, dependence, and withdrawal through dopamine receptor modulation.

U.S. Patent No. 11,925,635 (March 12, 2024)
Co-administration strategies and opioid dose reduction through mechanistic targeting of dopamine pathways.

U.S. Patent No. 12,383,551 (August 12, 2025)
Combination therapies, dosing regimens, and treatment paradigms that improve outcomes without sacrificing analgesic effectiveness.

Exclusive worldwide license from East Carolina University

Platform Protection

Our patents protect a therapeutic platform, not just a single product. Claims cover:

Combination opioid + adjunctive therapies
Pain treatment methods (acute and chronic)
Dose-reduction strategies
Dopamine pathway modulation relevant to tolerance and dependence

International Expansion

Strategic patent filings are underway in Europe and Canada, targeting markets with high opioid use, established regulatory pathways, and strong commercial potential.

Built on Validated Science

Preclinical data showing reduced tolerance and preserved analgesia
Clinical evidence supporting improved outcomes
Mechanistic understanding of dopamine-opioid pathway interactions

This alignment between patents, biology, and clinical data strengthens regulatory positioning and commercial value. Durable IP protection supporting both near-term development and long-term platform growth.

Products

AMGT-0220

Amalgent Therapeutics, Inc.’s lead product, AMGT-0220, is designed as a first-line treatment for moderate to severe pain in patients who would otherwise receive an immediate-release opioid monotherapy.

AMGT-0220 combines subtherapeutic doses of morphine with pramipexole—a Parkinson’s drug used here as a patent-protected, novel opioid adjuvant. This fixed-dose combination offers significant advantages:

it delivers effective pain relief at morphine doses lower than those available in pharmacies, establishing AMGT-0220 as a safer choice for pain management;
it provides an approved, safe formulation of pramipexole and morphine in a single therapy;
and it reduces the need to prescribe opioids alone, helping to limit a common source of street misuse.

AMGT-0220 Demonstrated Human Efficacy
For Pain Management

AMGT-0220 promises to provide physicians and patients with opioid-level efficacy and reduced side effects. A primary feature of the AMGT-0220 profile is its use of morphine at doses as low as 25% of the lowest available prescribed immediate-release doses, significantly increasing the therapeutic index of morphine.

Published data demonstrate that combining low doses of pramipexole with morphine:

a) mitigates the reward-seeking behavior of morphine,

b) prevents the development of opioid tolerance,

c) decreases opioid withdrawal symptoms, and

d) enhances the efficacy of morphine in treating neuropathic pain.

Together, these benefits make AMGT-0220 a compelling new option in pain management.

AMGT-0230

Amalgent Therapeutics, Inc. is advancing AMGT-0230 as a next-generation, extended-release therapy to address moderate to severe pain with a safer, non-addictive profile. Building upon the success of our first product, AMGT-0230 offers a novel fixed-dose combination, optimized to provide sustained pain relief at exceptionally low opioid doses that are currently unavailable in the market.

This innovative approach leverages pramipexole, a dopamine agonist widely used to treat Parkinson’s Disease, as a potent opioid adjuvant in enhancing opioid's efficacy.

AMGT-0240

AMGT-0240 is designed to reduce neural inflammation involved in immune response and swelling within the central nervous system (CNS). Neural inflammation has been widely demonstrated to be both associated and a causative agent of a wide-range of neurodegenerative diseases including Alzheimer’s, Parkinson’s, multiple sclerosis, and certain types of stroke. We anticipate that AMGT-0240 will act on inflammasome pathways, which are crucial in the production of pro-inflammatory cytokines.

An inherent advantage of AMGT-0240 is the existing demonstration that our adjuvant technology transports across the blood brain barrier that ensures the active compound reaches inflamed neural tissues.