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Status:
Possibly Marketed Outside US
Source:
NCT02469337: Phase 4 Interventional Unknown status Insulin Resistance
(2012)
Source URL:
First approved in 2011
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Dichloroacetic acid, often abbreviated DCA (dichloroacetate), is an acid analog of acetic acid in which two of the three hydrogen atoms of the methyl group have been replaced by chlorine atoms. The salts and esters of dichloroacetic acid are called dichloroacetates. Salts of DCA are used as drugs since they inhibit the enzyme pyruvate dehydrogenase kinase. Early reports of its activity against brain cancer cells led patients to treat themselves with DCA, which is commercially available in non-pharmaceutical grade. A phase 1 study in 5 patients concluded that DCA was safe, but wasn't designed to establish effectiveness.
DCA was approved for use in Canada in 1989 (as a topical formulation for the treatment of warts and for cauterization and removal of a wide variety of skin and tissue lesions), but was cancelled post market. DCA is a noncompetitive inhibitor of the endoplasmic reticulum enzyme HMG CoA reductase, which catalyzes the rate limiting step in cholesterol biosynthesis. DCA has been researched in adults, children, animals, and cells as a monotherapy as well as in
combination with other therapies for the treatment of severe metabolic disorders including diabetes and hypercholesterolemia, lactic acidosis, certain heart conditions, and cancer. DCA has been prescribed to reduce tumour size and tumour markers, prevent angiogenesis, reduce
cancer related symptoms, manage pain, and aid in palliation.
Status:
Possibly Marketed Outside US
Source:
NCT02469337: Phase 4 Interventional Unknown status Insulin Resistance
(2012)
Source URL:
First approved in 2011
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Dichloroacetic acid, often abbreviated DCA (dichloroacetate), is an acid analog of acetic acid in which two of the three hydrogen atoms of the methyl group have been replaced by chlorine atoms. The salts and esters of dichloroacetic acid are called dichloroacetates. Salts of DCA are used as drugs since they inhibit the enzyme pyruvate dehydrogenase kinase. Early reports of its activity against brain cancer cells led patients to treat themselves with DCA, which is commercially available in non-pharmaceutical grade. A phase 1 study in 5 patients concluded that DCA was safe, but wasn't designed to establish effectiveness.
DCA was approved for use in Canada in 1989 (as a topical formulation for the treatment of warts and for cauterization and removal of a wide variety of skin and tissue lesions), but was cancelled post market. DCA is a noncompetitive inhibitor of the endoplasmic reticulum enzyme HMG CoA reductase, which catalyzes the rate limiting step in cholesterol biosynthesis. DCA has been researched in adults, children, animals, and cells as a monotherapy as well as in
combination with other therapies for the treatment of severe metabolic disorders including diabetes and hypercholesterolemia, lactic acidosis, certain heart conditions, and cancer. DCA has been prescribed to reduce tumour size and tumour markers, prevent angiogenesis, reduce
cancer related symptoms, manage pain, and aid in palliation.
Status:
Possibly Marketed Outside US
Source:
DENAGARD by Novartis
Source URL:
First approved in 2010
Source:
NADA140916
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Tiamulin is a diterpene antimicrobial with a pleuromutilin chemical structure similar to that of
valnemulin. The activity of tiamulin is largely confined to gram-positive micro-organisms and
mycoplasma. Tiamulin acts by inhibiting protein synthesis at the ribosomal level. In veterinary
medicine, tiamulin is used for treatment and prophylaxis of dysentery, pneumonia and
mycoplasmal infections in pigs and poultry. Tiamulin is available as a 2, 10 or 20% premix for
pigs and poultry, a 12.5% solution or 45% water soluble powder for addition to drinking water
for pigs and poultry, or a 10% injectable formulation for pigs. Tiamulin inhibits protein synthesis by targeting the 50S bacterial ribosomal subunit and binding to peptidyl transferase, the enzyme responsible for forming peptide bonds between amino acids.
Status:
Possibly Marketed Outside US
Source:
NCT02140073: Phase 4 Interventional Unknown status GERD
(2013)
Source URL:
First approved in 2009
Source:
MIF900001
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Domperidone is a peripherally selective D2 receptor antagonist. It acts as an antiemetic and a prokinetic agent through its effects on the chemoreceptor trigger zone and motor function of the stomach and small intestine. Domperidone was not approved in USA due to risks of cardiac arrhythmias, cardiac arrest, and sudden death, but is available in other countries. However, FDA allows access to Domperidone through an expanded access investigational new drug application (IND) to patients with gastroesophageal reflux disease with upper GI symptoms, gastroparesis, and chronic constipation. As an “off-label” use, domperidone is prescribed to breastfeeding women to enhance their milk production.
Status:
Possibly Marketed Outside US
Source:
MIF900002
(2009)
Source URL:
First approved in 2009
Source:
MIF900002
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Metomidate is a non-barbiturate imidazole which produces a sleepy condition of 20-60 minutes duration without substantial analgesia. Since the beginning of 1997 the use of the hypnotic drug metomidate (Hypnodil) in swine is nor longer allowed. This ban caused a substantial therapeutic deficit for anesthesia in swine. 11C-metomidate may be used with positron emission tomography which can differentiate adrenocortical from nonadrenocortical tumors and a suspected adrenocortical cancer may be characterized and staged before surgery. Metomidate hydrochloride is for the sedation and anesthesia of aquarium and non-food fish species. Aquacalm has been granted Indexed status by the FDA for this purpose.
Status:
Possibly Marketed Outside US
Source:
NCT02140073: Phase 4 Interventional Unknown status GERD
(2013)
Source URL:
First approved in 2009
Source:
MIF900001
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Domperidone is a peripherally selective D2 receptor antagonist. It acts as an antiemetic and a prokinetic agent through its effects on the chemoreceptor trigger zone and motor function of the stomach and small intestine. Domperidone was not approved in USA due to risks of cardiac arrhythmias, cardiac arrest, and sudden death, but is available in other countries. However, FDA allows access to Domperidone through an expanded access investigational new drug application (IND) to patients with gastroesophageal reflux disease with upper GI symptoms, gastroparesis, and chronic constipation. As an “off-label” use, domperidone is prescribed to breastfeeding women to enhance their milk production.
Status:
Possibly Marketed Outside US
Source:
CIS-MDP by Schwarzenbach, G.|Zurc, J.
Source URL:
First approved in 2004
Source:
NDA018035
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Medronic acid (conjugate base, medronate) is a diagnostic agent that is used in complex with technetium Tc-99m for imaging delineate areas of altered osteogenesis. Upon administration the complex binds to hydroxyapatite crystals in bone.
Status:
Possibly Marketed Outside US
Source:
CIS-MDP by Schwarzenbach, G.|Zurc, J.
Source URL:
First approved in 2004
Source:
NDA018035
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Medronic acid (conjugate base, medronate) is a diagnostic agent that is used in complex with technetium Tc-99m for imaging delineate areas of altered osteogenesis. Upon administration the complex binds to hydroxyapatite crystals in bone.
Status:
Possibly Marketed Outside US
Source:
CIS-MDP by Schwarzenbach, G.|Zurc, J.
Source URL:
First approved in 2004
Source:
NDA018035
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Medronic acid (conjugate base, medronate) is a diagnostic agent that is used in complex with technetium Tc-99m for imaging delineate areas of altered osteogenesis. Upon administration the complex binds to hydroxyapatite crystals in bone.
Status:
Possibly Marketed Outside US
Source:
CIS-MDP by Schwarzenbach, G.|Zurc, J.
Source URL:
First approved in 2004
Source:
NDA018035
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Medronic acid (conjugate base, medronate) is a diagnostic agent that is used in complex with technetium Tc-99m for imaging delineate areas of altered osteogenesis. Upon administration the complex binds to hydroxyapatite crystals in bone.