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Search results for pantothenic root_modifications_structuralModifications_molecularFragment_refPname in root_modifications_structuralModifications_molecularFragment_refPname (approximate match)
Status:
US Previously Marketed
Source:
OMONTYS PRESERVATIVE FREE by TAKEDA PHARMS USA
(2012)
Source URL:
First approved in 2012
Source:
OMONTYS PRESERVATIVE FREE by TAKEDA PHARMS USA
Source URL:
Class:
PROTEIN
Targets:
Conditions:
Peginesatide (trade name Omontys, formerly Hematide), developed by Affymax and Takeda, is an erythropoietic agent, a functional analog of erythropoietin. It was approved by the U.S. Food and Drug Administration for treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis. Peginesatide is a synthetic peptide, attached to polyethylene glycol ("PEGylated"). It mimics the structure of erythropoietin, the human glycoprotein which promotes red blood cell development. Peginesatide binds to and activates the human erythropoietin receptor and stimulates erythropoiesis in human red cell precursors in vitro.
Status:
US Previously Marketed
Source:
GEREF by EMD SERONO INC
(1997)
Source URL:
First approved in 1990
Source:
GEREF by EMD SERONO
Source URL:
Class:
PROTEIN
Conditions:
Sermorelin, a 29 amino acid analog of human growth hormone-releasing hormone (GHRH), is the shortest synthetic peptide with a full biological activity of GHRH which is used as a diagnostic agent to assess growth hormone (GH) secretion for the purpose of diagnosing growth hormone deficiency. Intravenous and subcutaneous sermorelin specifically stimulate growth hormone secretion from the anterior pituitary. Sermorelin binds to the growth hormone releasing hormone receptor and mimics native GRF in its ability to stimulate growth hormone secretion. Hormone responses to intravenous sermorelin appear to be a rapid and relatively specific test for the diagnosis of growth hormone deficiency.
Status:
US Previously Marketed
Source:
SARENIN by PROCTER AND GAMBLE
(1981)
Source URL:
First approved in 1981
Source:
SARENIN by PROCTER AND GAMBLE
Source URL:
Class:
PROTEIN
Targets:
Conditions:
Saralasin is an angiotensin II analogue which was developed for the treatment of hypertension in 1970s. For many years saralasin was supposed to be angiotensin receptors blocker, but recent studies have revealed that its pharmacological action can be explained by agonistic behavior toward angiotensin II receptor. The drug was approved by FDA under the name Sarenin, however, it is no longer available on the market.
Status:
US Previously Marketed
Source:
FACTREL by HIKMA
(1982)
Source URL:
First approved in 1978
Source:
NADA098379
Source URL:
Class:
PROTEIN
Targets:
Conditions:
Gonadorelin is a synthetic decapeptide prepared using solid phase peptide synthesis. GnRH is responsible for the release of follicle stimulating hormone and leutinizing hormone from the anterior pitutitary. In the pituitary GnRH stimulates synthesis and release of FSH and LH, a process that is controlled by the frequency and amplitude of GnRH pulses, as well as the feedback of androgens and estrogens. The pulsatility of GnRH secretion has been seen in all vertebrates, and it is necessary to ensure a correct reproductive function. Thus a single hormone, GnRH, controls a complex process of follicular growth, ovulation, and corpus luteum maintenance in the female, and spermatogenesis in the male. Its short half life requires infusion pumps for its clinical use. Gonadorelin is used for the treatment of amenorrhea, delayed puberty, and infertility the administration of gonadorelin is used to simulate the physiologic release of GnRH from the hypothalamus in treatment of delayed puberty, treatment of infertility caused by hypogonadotropic hypogonadism, and induction of ovulation in those women with hypothalamic amenorrhea. This results in increased levels of pituitary gonadotropins LH and FSH, which subsequently stimulate the gonads to produce reproductive steroids.
Status:
US Previously Marketed
Source:
FACTREL by HIKMA
(1982)
Source URL:
First approved in 1978
Source:
NADA098379
Source URL:
Class:
PROTEIN
Targets:
Conditions:
Gonadorelin is a synthetic decapeptide prepared using solid phase peptide synthesis. GnRH is responsible for the release of follicle stimulating hormone and leutinizing hormone from the anterior pitutitary. In the pituitary GnRH stimulates synthesis and release of FSH and LH, a process that is controlled by the frequency and amplitude of GnRH pulses, as well as the feedback of androgens and estrogens. The pulsatility of GnRH secretion has been seen in all vertebrates, and it is necessary to ensure a correct reproductive function. Thus a single hormone, GnRH, controls a complex process of follicular growth, ovulation, and corpus luteum maintenance in the female, and spermatogenesis in the male. Its short half life requires infusion pumps for its clinical use. Gonadorelin is used for the treatment of amenorrhea, delayed puberty, and infertility the administration of gonadorelin is used to simulate the physiologic release of GnRH from the hypothalamus in treatment of delayed puberty, treatment of infertility caused by hypogonadotropic hypogonadism, and induction of ovulation in those women with hypothalamic amenorrhea. This results in increased levels of pituitary gonadotropins LH and FSH, which subsequently stimulate the gonads to produce reproductive steroids.
Status:
US Previously Marketed
First approved in 1978
Class:
PROTEIN
Seractide is a polypeptide hormone corresponding to thirty-nine amino acids of human corticotropin that differs from full-length human corticotropin at four positions. Seractide is potent endogenous melanocortin receptor 2 (MC ) agonist. Seractide stimulates the cortex of the adrenal gland and boosts the synthesis of corticosteroids, mainly glucocorticoids but also sex steroids (androgens). Seractide, was approved by FDA in 1978, but was never marketed. The Seractide, that was ultimately withdrawn by FDA in 2014 for safety reasons.
Status:
Possibly Marketed Outside US
First approved in 2013
Source:
BLA125421
Source URL:
Class:
PROTEIN
Status:
Possibly Marketed Outside US
Source:
Octaplex by Octapharma Pharmazeutika Produktionsges M B H [Canada]
Source URL:
First approved in 2007
Source:
BLA125234
Source URL:
Class:
PROTEIN
Status:
Possibly Marketed Outside US
Class:
PROTEIN
Corticorelin (Xerecept) is a synthetic analog of the naturally occurring human peptide corticotropin-releasing factor (CRF). Corticotropin-releasing factor is the predominant regulator of adrenocorticotropic-hormone (ACTH) formation and release by the pituitary. In addition to its primary location in the hypothalamic paraventricular nucleus, endogenous CRF has also been identified in cerebral cortical interneurons, the limbic system, brain stem and spinal cord. Several studies have indicated the ability of CRF to reduce the brain edema caused by brain tumors. Clinical trials with the Corticorelin (Xerecept) have indicated that this drug has a distinct advantage over classical corticosteroids in the treatment of brain edema. Fewer and/or milder side effects have been reported for corticorelin compared with dexamethasone, although at higher doses of corticorelin several side effects, including hypotension and transient flushing, have been reported.
Status:
US Approved Rx
(2023)
Source:
ANDA212886
(2023)
Source URL:
First approved in 2000
Source:
WELCHOL by COSETTE
Source URL:
Class:
POLYMER
Targets:
Colesevelam (trade name Welchol) a non-absorbed, polymeric, lipid-lowering agent intended for oral administration. Colesevelam is poly(allylamine hydrochloride) cross-linked with epichlorohydrin and alkylated with 1-bromodecane and (6-bromohexyl)-trimethylammonium bromide. Colesevelam hydrochloride is a hydrophilic, water-insoluble polymer that is not hydrolyzed by digestive enzymes and is not absorbed. Colesevelam is part of a class of drugs known as bile acid sequestrants. Colesevelam hydrochloride, the active pharmaceutical ingredient in Welchol, is a non-absorbed, lipid-lowering polymer that binds bile acids in the intestine, impeding their reabsorption. As the bile acid pool becomes depleted, the hepatic enzyme, cholesterol 7-α-hydroxylase, is upregulated, which increases the conversion of cholesterol to bile acids. This causes an increased demand for cholesterol in the liver cells, resulting in the dual effect of increasing transcription and activity of the cholesterol biosynthetic enzyme, HMG-CoA reductase, and increasing the number of hepatic LDL receptors. These compensatory effects result in increased clearance of LDL-C from the blood, resulting in decreased serum LDL-C levels. Colesevelam is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in patients with primary hyperlipidemia as monotherapy and to improve glycemic control in adults with type 2 diabetes mellitus, including in combination with a statin. The expanded use of colesevelam in adults with type 2 diabetes mellitus is an example of drug repositioning.