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Restrict the search for
obeticholic acid
to a specific field?
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 2014
Source:
21 CFR 352
Source URL:
Class:
PROTEIN
Targets:
Thymopentin is a synthetic pentapeptide which is the active site of the naturally occurring hormone thymopoietin with immunomodulating properties. Thymopentin can specifically promote the differentiation and maturation of thymic T cells and natural killer cells (NK) and enhance the function of T helper cells. thymic can achieve a two-way adjustment to the immune system by increasing the levels of intracellular cyclic adenosine monophosphate, elevating the activity of T cells, and regulating the proportions of T cell subsets. As an immunomodulating agent, Thymopentin is clinically used in the treatments of autoimmune diseases, such as e.g. atopic dermatitis, chronic lymphocytic leukemia, Sezary's syndrome, rheumatoid arthritis, as well as decreased immune competency in elder surgical patients. Due to poor membrane permeability, extensive metabolism in the GI, and extremely short half-life of 30 s, repeated injections or i.v infusions of Thymopentin are necessary which greatly restrict its clinical applications.
Status:
Possibly Marketed Outside US
First approved in 2013
Source:
BLA125421
Source URL:
Class:
PROTEIN
Status:
Possibly Marketed Outside US
First approved in 2012
Source:
21 CFR 346
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
Source:
BLA102475
(1978)
Source URL:
First approved in 1978
Source:
BLA102475
Source URL:
Class:
PROTEIN
Status:
Possibly Marketed Outside US
Class:
PROTEIN
Somatorelin is 29 amino acid analogue of human growth hormone-releasing hormone used as a diagnostic agent for determining growth hormone deficiency. Growth-hormone-releasing hormone (GHRH, somatoliberin) is the hypothalamic peptide hormone that specifically stimulates synthesis and release of growth hormone (GH, somatotropin) by somatotrope cells of the anterior pituitary gland. The hypothalamic hormone growth hormone (GH)-releasing hormone (GHRH) acts on specific GHRH receptors (GHRH-R) in the anterior pituitary gland to stimulate the synthesis and secretion of GH and to promote somatotrope expansion. Somatorelin is applied to determine the somatotropic function of the anterior pituitary gland in cases of suspected growth hormone deficiency. The test distinguishes between pituitary and hypothalamic disorders but is not suitable as a screening test for growth hormone deficiencies. Somatorelin has been used in trials studying the treatment of Aging, Elderly, Sleep Disorders, Hormone Deficiency, and Mild Cognitive Impairment.
Status:
Possibly Marketed Outside US
Class:
PROTEIN
YTTRIUM Y-90 (YTRACIS®, YTTRIGA®) is a radioactive form of the chemical element yttrium. It is used for radiolabelling other medicines. An example of its use is the treatment of some type of tumors, where the radiolabelled medicine carries the radioactivity to the site of a tumor to destroy the tumor cells.