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Search results for "EU ORPHAN DRUG" in comments (approximate match)
Status:
US Approved Rx
(1996)
Source:
BLA020604
(1996)
Source URL:
First approved in 1976
Class:
PROTEIN
Status:
US Approved OTC
Source:
21 CFR 346.18(a) anorectal:astringent calamine
Source URL:
First marketed in 1921
Class:
PROTEIN
Targets:
Conditions:
There is no available information related any biological and pharmaceutical application of ammonium tetrachlorozincate.
Status:
Investigational
Source:
NCT01796171: Phase 1/Phase 2 Interventional Completed Non-Hodgkin Lymphoma
(2012)
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.
Status:
US Previously Marketed
Source:
Bexxar
(2003)
Source URL:
First approved in 2003
Source:
Bexxar
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2018)
Source:
NDA210922
(2018)
Source URL:
First approved in 2018
Source:
NDA210922
Source URL:
Class:
NUCLEIC ACID
Status:
US Approved Rx
(2016)
Source:
NDA209531
(2016)
Source URL:
First approved in 2016
Source:
NDA209531
Source URL:
Class:
NUCLEIC ACID
Status:
Investigational
Source:
INN:atesidorsen [INN]
Source URL:
Class:
NUCLEIC ACID
Status:
Investigational
Source:
NCT02658175: Phase 3 Interventional Completed Familial Chylomicronemia Syndrome
(2015)
Source URL:
Class:
NUCLEIC ACID
Status:
Designated
Source:
EU-Orphan Drug:EU/3/19/2171
Source URL:
Class:
NUCLEIC ACID
