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Search results for "ORPHAN DRUG" in comments (approximate match)
Status:
Possibly Marketed Outside US
Source:
Cernevit by Lohmann, K.|Schuster, P.H.
Source URL:
First approved in 2011
Source:
EnLyte by Jaymac Pharma
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Cocarboxylase is the coenzyme form of Vitamin B1 present in many animal tissues. Thiamine pyrophosphate (cocarboxylase) is the active form of thiamine, and it serves as a cofactor for several enzymes involved primarily in carbohydrate catabolism. Pancreatic cells obtain thiamin from their surroundings and enzymatically convert it into thiamin pyrophosphate (TPP) in the cytoplasm; TPP is then taken up by mitochondria via a specific carrier the mitochondrial TPP transporter (MTPPT; product of the SLC25A19 gene).
Status:
Possibly Marketed Outside US
Source:
21 CFR 348
(2010)
Source URL:
First approved in 2010
Source:
21 CFR 348
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
CETYL PALMITOLEATE is a wax ester obtained by the formal condensation of hexadecan-1-ol with palmitoleic acid. It is a component of EVERFLEX® Cream, a topical analgesic which provides temporary relief from aching joints and the surrounding tissues.
Status:
Possibly Marketed Outside US
Source:
NCT00647036: Phase 4 Interventional Completed Surgical Infants Requiring Total Parenteral Nutrition
(2009)
Source URL:
First approved in 2010
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Alanyl-glutamine is a widely used alternative supplement to L-glutamine in the production of biopharmaceuticals. The primary advantage of using L-alanyl-glutamine in place of L-glutamine is that it reduces the level of ammonia generated during cell culture. L-alanyl glutamine also acts as an antioxidant (peroxide) and anti-apoptosis (LPS-induced) factor. Ala-Glu may be used in cell culture and insect cell culture applications. It can be used in studies on injury and sepsis, and in the effects of irradiation on leucine and protein metabolism in vivo. Alanyl-glutamine is used as dipeptide infusion solution, which is given as part of parenteral and/or enteral nutritional therapy. When the intake of nutrients or food into the mouth or directly into the gut is not possible or it is not enough to supply the body’s needs then nutrients or foods can be given intravenously or through the gastrointestinal tract or a combination of both. This is especially important for people whose bodies are under physical stress from illness or recent surgery. During illness or after surgery the body requires nutrition or food. Amino acids are the building blocks used by the body to make proteins. Dipeptiven is usually given as a supplement to amino acid solutions or an amino acid containing infusion regimen as part of complete nutritional support.
Status:
Possibly Marketed Outside US
Source:
NCT00001521: Phase 4 Interventional Completed Congenital Adrenal Hyperplasia (CAH)
(1995)
Source URL:
First approved in 2010
Source:
NADA141319
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Deslorelin is an GnRH agonist used in veterinary. It effects contraception by temporarily suppressing the reproductive endocrine system and preventing production of pituitary (FSH and LH) and gonadal hormones (estradiol and progesterone in females and testosterone in males). The observed effects are similar to those following ovariectomy or castration, but are reversed after the hormone content of the implant is depleted or the implant is removed. As an agonist, deslorelin first stimulates the reproductive system, which can result in estrus and ovulation in females or temporary enhancement of testosterone and semen production in males. Then, down-regulation follows the initial period of stimulation.
Although deslorelin can also be an effective contraceptive in males of some species, manufacturer recommends its use primarily in females, since monitoring efficacy in females by suppression of estrous behavior or of gonadal steroids in feces is more straightforward than ensuring continued absence of sperm in males, since most institutions cannot perform regular semen collections. It can, however, be used to ameliorate aggression in males of some species, but higher dosages are usually needed.
While the major application of deslorelin was initially male contraception, due to its two differing actions, either the stimulation of oestrus or the sterilization of fertility, its use has been increasing in the bitch as well.
SUPRELORIN® F (deslorelin acetate) Implant is a once-yearly, subcutaneous implant that assists in the management of adrenal disease in ferrets.
Status:
Possibly Marketed Outside US
Source:
21 CFR 348
(2010)
Source URL:
First approved in 2010
Source:
21 CFR 348
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Cetyl myristoleate (CMO) is the hexadecyl ester of myristoleic acid. Whereas myristoleic acid is commonly found in fish oils, whale oils, and dairy butter, CMO is known to exist only naturally in sperm whale oil and in a small gland in the male beaver. Cetyl myristoleate is effective in alleviating knee pain in persons with mild degree arthritis of the knee joint.
Status:
Possibly Marketed Outside US
Source:
Synanthic Bovine Dewormer by Coopers
Source URL:
First approved in 2010
Source:
NADA140854
Source URL:
Class (Stereo):
CHEMICAL (UNKNOWN)
Oxfendazole is a broad spectrum benzimidazole anthelmintic. Oxfendazole has broad-spectrum activity against inhibited larval
stages of gastrointestinal roundworms, tapeworms, and lungworms in many animal species at doses between 4.5–10 mg/kg.
Status:
Possibly Marketed Outside US
Source:
NCT04528212: Phase 4 Interventional Completed Diabetes Mellitus, Type 2
(2020)
Source URL:
First approved in 2009
Source:
21 CFR 348
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Curcumin is a bright yellow chemical produced by some plants, for example, it is the principal curcuminoid of turmeric. It is sold as a food flavoring, food colorant, herbal supplement, and cosmetic ingredient. Although curcumin has been widely studied it has not been officially endorsed for any pharmaceutical use due to issues of stability and bioavailability; although it continues to b marketed as a health supplement. Curcumin has been investigated for the treatment of a number of cancers, asthma, mucositis, schizophrenia, mild cognitive impairment, and depression.
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:
NCT03394950: Phase 4 Interventional Completed Stroke, Ischemic
(2018)
Source URL:
First approved in 2009
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
3-N-Butylphthalide (NBP), a family comprised of optical isomers l-3-N-butylphthalide (l-NBP) and d-3-N-butylphthalide (d-NBP), with l-NBP being an extract from seeds of Apium graveolens Linn. (celery) and dl-3-N-butylphthalide (dl-NBP), a synthetized version, has been studied for its significant neuroprotective effects. NBP showed neuroprotective effects by decreasing oxidative damage, inhibiting inflammatory responses, improving mitochondrial function, and reducing
neuronal apoptosis. NBP received approval by the State Food and Drug Administration of China for clinical use in stroke patients in 2002. It demonstrates a potential for the treatment of central nervous system diseases, including Parkinson’s disease, Alzheimer’s disease.
Status:
Possibly Marketed Outside US
Source:
21 CFR 348
(2010)
Source URL:
First approved in 2009
Source:
21 CFR 347
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Cetyl oleate is a cosmetic emollient ester