U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

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Status:
Investigational
Source:
NCT04500132: Phase 2 Interventional Completed COVID-19
(2020)
Source URL:

Class (Stereo):
CHEMICAL (RACEMIC)

EC-18 (now known as mosedipimod), a synthetic copy of 1-palmitoyl-2-linoleoyl-3-acetyl-rac-glycerol (PLAG) that was developed by Enzychem Lifescience for oral administration for the treatment of immune and inflammatory related diseases, including psoriasis, rheumatoid arthritis, asthma, atopic dermatitis, and sepsis. The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to EC-18 for the treatment of Acute Radiation Syndrome (ARS) and for the for the neutropenia treatment. Besides, the EC-18 is participating in phase II clinical trials to investigate the efficacy and safety of the agent for chemoradiation-induced oral mucositis and chemotherapy-induced neutropenia. This drug has a multimodal mechanism of action. It stimulates calcium influx into T lymphocytes and increases the production of various cytokines. In addition, EC-18 enhances the cytolytic activity of natural killer (NK) cells and suppresses the expression of the transmembrane protein tumor cell toll-like receptor 4 (TLR-4) on cancer cells, thus suppresses tumor cell proliferation.
Status:
Investigational
Source:
NCT03593421: Phase 2 Interventional Withdrawn Panel Reactive Antibodies
(2019)
Source URL:

Class (Stereo):
CHEMICAL (ABSOLUTE)

Status:
US Previously Marketed
Source:
melatonin
(1921)
Source URL:
First marketed in 1921
Source:
melatonin
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)



Melatonin (5-methoxy N-acetyltryptamine) is a hormone synthesized and released from the pineal gland at night, which acts on specific high affinity G-protein coupled receptors to regulate various aspects of physiology and behaviour, including circadian and seasonal responses, and some retinal, cardiovascular and immunological functions. Melatonin is also made synthetically and available without a prescription as an over-the-counter (OTC) dietary supplement in the U.S. Melatonin supplementation has many uses, however, it has been widely studied for treatment of jet lag and sleep disorders. Parents may consider using melatonin to help their child who has a trouble falling asleep. A medical professional should always evaluate insomnia or other sleeping disorders in children. Additionally, melatonin has been shown to protect against oxidative stress in various, highly divergent experimental systems. There are many reasons for its remarkable protective potential. In mammals, melatonin binds to a number of receptor subtypes including high-affinity (MT1 and MT2) and low-affinity (MT3, nuclear orphan receptors) binding sites, which are distributed throughout the central nervous system and periphery.
Status:
Possibly Marketed Outside US
Source:
NCT00219375: Phase 4 Interventional Completed Acute Lung Injury
(2004)
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)



Sivelestat is a neutrophil elastase inhibitor approved in Japan and the Republic of Korea for acute lung injury, including acute respiratory distress syndrome in patients with systemic inflammatory response syndrome. Sivelestat is marketed as Elaspol in Japan. Sivelestat competitively inhibited human neutrophil elastase (IC50 = 0.044 uM, Ki = 0.2 uM). It also inhibited leukocyte elastase obtained from rabbit, rat, hamster and mouse.
Status:
Possibly Marketed Outside US
Source:
NCT03154515: Phase 4 Interventional Completed Common Cold
(2010)
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)

Ingavirin is pentanedioic acid imidazolyl ethanamide used for the treatment of Influenza and Common Cold in Russia and some other countries. The mechanism of action is implemented at the level of infected cells due to the stimulation of innate immunity factors suppressed by viral proteins. The drug causes an increase in the content of interferon in the blood to the physiological norm, stimulates and normalizes the reduced α-interferon-producing ability of blood leukocytes, stimulates the γ-interferon-producing ability of leukocytes.
Status:
Investigational
Source:
NCT03237325: Phase 3 Interventional Completed Squamous Cell Carcinoma of the Oral Cavity and Oropharynx
(2017)
Source URL:

Class:
PROTEIN

Dusquetide (also referred to by its research name SGX94) is a fully synthetic, 5-amino acid peptide with high aqueous solubility and stability. Preclinical data indicate that dusquetide is active in models of a wide range of therapeutic indications including severe side-effects of chemo- and/or radiation-therapy and life-threatening bacterial infections. Dusquetide, a novel Innate Defense Regulator, has demonstrated both nonclinical and clinical efficacy in ameliorating severe oral mucositis (SOM). Long term follow-up studies from the Phase 2 clinical study evaluating dusquetide as a treatment for SOM in head and neck cancer (HNC) patients receiving CRT have now been completed. Extended analysis indicates that dusquetide therapy was well-tolerated and did not contribute to increased infection, tumor growth or mortality. Potential ancillary benefits of duquetide therapy were also identified. A multi-center, double-blind, placebo-controlled, pivital Phase 3 clinical study in oral mucositis in head and neck cancer patients has been initiated.
Status:
Possibly Marketed Outside US
Source:
NCT02647554: Phase 4 Interventional Completed Sepsis
(2016)
Source URL:

Class:
PROTEIN

Status:
Investigational
Source:
NCT00131482: Phase 2 Interventional Terminated Radius Fracture
(2004)
Source URL:

Class:
PROTEIN

Rusalatide acetate (also known as chrysalin or TP 508) is a 23-amino acid peptide derived from human prothrombin; it represents part of the receptor-binding domain of the human thrombin molecule. Rusalatide acetate binds to high-affinity thrombin receptors and mimics cellular effects of thrombin at sites of tissue injury. Rusalatide acetate demonstrated safety and potential efficacy in phase I/II clinical trials for the treatment of diabetic foot ulcers. It interacts with cell surface receptors to stimulate a cascade of cellular and molecular wound healing events, including activation of nitric oxide signaling. In addition, this drug participated in phase II clinical trial to determine the effectiveness of four doses for treating broken wrists in adults. However, this study was terminated because the drug did not demonstrate benefit compared to placebo. Rusalatide acetate was also studied as a cardiovascular drug. However, in January 2012, Capstone discontinued the development of rusalatide, for financial reasons. Recent studies show that a single injection of TP508 (rusalatide acetate) administered 24 h after irradiation significantly increases survival and delays mortality in murine models of acute radiation mortality. Thus, this drug is being developed as a potential nuclear countermeasure.