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Search results for "ORPHAN DRUG|Designated|Treatment of Malaria" in comments (approximate match)
Status:
US Approved Rx
(2015)
Source:
ANDA203112
(2015)
Source URL:
First marketed in 1921
Source:
Quinine Dihydrochloride U.S.P.
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Quinine soluble salts possess the extremely bitter taste, that may have a perplexing problem especially to children. That is why the most common combinations which are administered in this way are the sulphate, salicylate, tannate and certain esters. Quinine tannate, an insoluble quinine salt has been known in medicine for a very long time. However, many experiments have revealed that quinine tannate was practically inert as a medicinal substance.
Status:
Investigational
Source:
NCT02083380: Phase 2/Phase 3 Interventional Completed Uncomplicated Plasmodium Falciparum Malaria
(2014)
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Artefenomel, a novel trioxolane, is a lead candidate for inclusion in a new antimalarial combination, specifically formulated for children.
Artefenomel has been demonstrated curative in as little as one dose.
Status:
Investigational
Source:
NCT01614964: Phase 2 Interventional Completed Malaria
(2013)
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
AQ-13 is a drug candidate in development for the treatment of Plasmodium falciparum infections. The chemical structure is similar to chloroquine, a 4-aminoquinoline, with a shorter diaminoalkane side chain. The outstanding attribute of AQ-13 is its retrieval of activity against chloroquine-resistant P.falciparum. The most likely future indication of AQ-13 could be case management of uncomplicated falciparum malaria - as a partner drug in a combination therapy.
Status:
Investigational
Source:
NCT00803933: Phase 2 Interventional Completed African Trypanosomiasis
(2003)
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Pafuramidine or DB289, [2,5-bis-(4-amidinophenyl)furan bis-O-methylamidoxime] is a pro-drug of DB75, [2,5-bis(4-amidinophenyl)furan] also known as furamidine. The biotransformation process of DB289 to DB75 in the human liver consists of three O-demethylation reactions
catalyzed by the Cyp4F enzyme subfamily and three N-dehydroxylation reactions catalyzed by cytrochrome b5 and NADH-cytochrome b5 reductase. DB289 was studied for therapeutic treatment against human African trypanosomiasis, Pneumocystis pneumonia and malaria. In November 2006, Immtech Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) had granted orphan drug designation for pafuramidine (DB289) to treat Pneumocystis jiroveci pneumonia (PCP), a common life-threatening opportunistic infection in HIV/AIDS and other immunosuppressed patients. Despite the high efficacy of DB289 in patients, the mechanism of action of DB75 is unknown. The mechanism of antimicrobial activity of diamidine compounds is incompletely understood. They undergo active uptake by purine transporter systems in trypanosomes and their mechanism of action may involve interference with DNA-associated enzymes inhibition of heme crystallization11 or/and collapse of the transmitochondrial membrane potential.
Status:
Possibly Marketed Outside US
Source:
NCT03201770: Phase 4 Interventional Completed Malaria,Falciparum
(2017)
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Pyronaridine was developed in China and has been registered in that country since the 1980s. Outside China, none of the existing formulations is registered because of the failure to meet international regulatory standards. Pyronaridine is generally active against chloroquine-resistant parasites. Pyronaridine has been investigated for the treatment of Malaria. Pyronaridine targets hematin. Combination of pyronaridine with artesunate was indicated for the blood-stage treatment of both strains of malaria: P. falciparum and P. vivax. WHO currently recommends artesunate-pyronaridine in areas where other artemisinin-based combination therapies are failing.