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Status:
US Approved Rx
(2019)
Source:
NDA211280
(2019)
Source URL:
First approved in 2019
Source:
NDA211280
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
LASMIDITAN is a serotonin (5-HT) receptor agonist without vasoconstrictor activity, which selectively binds to the 5-HT(1F) receptor subtype. It is under development for the treatment of migraine.
Status:
US Approved Rx
(2024)
Source:
NDA218347
(2024)
Source URL:
First approved in 2019
Source:
NDA211675
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Upadacitinib (ABT-494) is a Janus kinase 1 (JAK1) inhibitor currently being developed by AbbVie for the treatment of rheumatoid arthritis (RA), Crohn’s disease, ulcerative colitis, atopic dermatitis, and psoriatic arthritis. It is also being investigated as a potential treatment for people with active ankylosing spondylitis (AS). Currently, upadacitinib is being evaluatedin six global phase III studies in RA and twophase III studies in psoriatic arthritis (PsA), inaddition to phase II studies in Crohn’s disease and atopicdermatitis and a combined phase II/III study inulcerative colitis. Upadacitinib is a potent and selective Janus kinase (JAK) 1 inhibitor with an IC50 of 43 nM.
Status:
US Approved Rx
(2019)
Source:
NDA209445
(2019)
Source URL:
First approved in 2019
Source:
NDA209445
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
US Approved Rx
(2019)
Source:
NDA209884
(2019)
Source URL:
First approved in 2019
Source:
NDA209884
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Siponimod (BAF312) is a dual agonist at the sphingosine-1 phosphate receptors, S1PR1 and S1PR5. The S1P receptor is commonly found on the surface of specific cells residing in the central nervous system (CNS), that are responsible for causing CNS damage that drives loss of function in secondary progressive multiple sclerosis (SPMS). Siponimod (BAF312) enters the brain and by binding to these specific receptors, may prevent the activation of these harmful cells, helping to reduce the loss of physical and cognitive function associated with SPMS.
Status:
US Approved Rx
(2024)
Source:
NDA218347
(2024)
Source URL:
First approved in 2019
Source:
NDA211675
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Upadacitinib (ABT-494) is a Janus kinase 1 (JAK1) inhibitor currently being developed by AbbVie for the treatment of rheumatoid arthritis (RA), Crohn’s disease, ulcerative colitis, atopic dermatitis, and psoriatic arthritis. It is also being investigated as a potential treatment for people with active ankylosing spondylitis (AS). Currently, upadacitinib is being evaluatedin six global phase III studies in RA and twophase III studies in psoriatic arthritis (PsA), inaddition to phase II studies in Crohn’s disease and atopicdermatitis and a combined phase II/III study inulcerative colitis. Upadacitinib is a potent and selective Janus kinase (JAK) 1 inhibitor with an IC50 of 43 nM.
Status:
US Approved Rx
(2019)
Source:
NDA212327
(2019)
Source URL:
First approved in 2019
Source:
NDA212327
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Fedratinib (SAR-302503, TG-101348) is a selective small-molecule inhibitor of Janus kinase-2. Fedratinib demonstrated therapeutic efficacy in a murine model of myeloproliferative disease. Sanofi was developing Fedratinib for the treatment of myeloproliferative diseases and solid tumors.
The clinical development of fedratinib was terminated after reports of Wernicke's encephalopathy in myelofibrosis patients.
Status:
US Approved Rx
(2019)
Source:
NDA209445
(2019)
Source URL:
First approved in 2019
Source:
NDA209445
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
US Approved Rx
(2019)
Source:
NDA209445
(2019)
Source URL:
First approved in 2019
Source:
NDA209445
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
US Approved Rx
(2019)
Source:
NDA211150
(2019)
Source URL:
First approved in 2019
Source:
NDA211150
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Pitolisant (INN) or tiprolisant (USAN) is a histamine receptor inverse agonist/antagonist selective for the H3 subtype. It has stimulant and nootropic effects in animal studies and may have several medical applications, having been researched for the treatment of narcolepsy, for which it has been granted orphan drug status in the EU and US. It is currently in clinical trials for schizophrenia and Parkinson’s disease. Pitolisant hydrochloride was approved by European Medicine Agency (EMA) on Mar 31, 2016. It was developed and marketed as Wakix® by Bioprojet in EU. Wakix® is available as the tablet for oral use, containing 4.5 mg and 18 mg of Pitolisant hydrochloride. The initial dose of 9 mg (two 4.5 mg, tablets) per day, and it should be used at the lowest effective dose, depending on individual patient response and tolerance, according to an up-titration scheme, without exceeding the dose of 36 mg/day. Pitolisant was the first clinically used H3 receptor inverse agonist.
Status:
US Approved Rx
(2019)
Source:
NDA212819
(2019)
Source URL:
First approved in 2019
Source:
NDA212819
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Relebactum sodium (MK-7655) is a piperidine analog 3 that inhibits class A and C β-lactamases (in vitro). It is being investigated for use in treatment of infectious diseases, such as treatment of gram-negative bacterial infections. Its potential as an alternative to existing medicines in the treatment of drug-resistant bacterial infections is being studied. Clinical trials have been conducted and are still ongoing to evaluate the efficacy and safety of relebactum sodium in treatment of intra-abdominal infections, urinary tract infections (such as pyelonephritis), hospital-acquired and ventilator-associated bacterial pneumonias, and gram-negative bacterial infections.