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Search results for "ORPHAN DRUG" in comments (approximate match)
Status:
US Previously Marketed
Source:
GEREF by EMD SERONO
(1990)
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:
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.
Status:
US Approved Rx
(2018)
Source:
NDA210922
(2018)
Source URL:
First approved in 2018
Source:
NDA210922
Source URL:
Class:
NUCLEIC ACID
Status:
US Approved Rx
(2016)
Source:
NDA209531
(2016)
Source URL:
First approved in 2016
Source:
NDA209531
Source URL:
Class:
NUCLEIC ACID
Status:
Investigational
Source:
NCT02580552: Phase 1 Interventional Completed Cutaneous T-cell Lymphoma (CTCL)
(2016)
Source URL:
Class:
NUCLEIC ACID
Status:
Investigational
Source:
NCT03865082: Phase 2 Interventional Active, not recruiting Solid Tumor
(2019)
Source URL:
Class:
NUCLEIC ACID
Status:
Investigational
Source:
INN:atesidorsen [INN]
Source URL:
Class:
NUCLEIC ACID
Status:
Investigational
Source:
NCT02658175: Phase 3 Interventional Completed Familial Chylomicronemia Syndrome
(2015)
Source URL:
Class:
NUCLEIC ACID
Status:
Investigational
Source:
NCT01899729: Phase 2 Interventional Completed Plaque Psoriasis
(2013)
Source URL:
Class:
NUCLEIC ACID
Status:
Designated
Source:
FDA ORPHAN DRUG:173903
Source URL:
Class:
NUCLEIC ACID