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Restrict the search for
m ulipristal acetate
to a specific field?
Status:
US Approved Rx
(2019)
Source:
NDA211672
(2019)
Source URL:
First approved in 2019
Source:
NDA211672
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
LEFAMULIN is a pleuromutilin antibiotic under development for the treatment of community-acquired bacterial pneumonia, as well as acute bacterial skin and skin structure infections. It inhibits bacterial protein synthesis by binding to the peptidyl transferase center of the 50S ribosome, resulting in the cessation of bacterial growth.
Status:
US Approved Rx
(2019)
Source:
NDA211230
(2019)
Source URL:
First approved in 2019
Source:
NDA211230
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
ADX-N05, originally discovered by SK Holdings, is a selective dopamine and norepinephrine reuptake inhibitor (DNRI). ADX-N05 (Solriamfetol, sold under the brand name Sunosi) is approved in the US and is under regulatory review in the EU to improve wakefulness in adult patients with hypersomnia associated with narcolepsy or obstructive sleep apnoea.The US FDA has approved solriamfetol (Sunosi, Jazz Pharmaceuticals) for the treatment of excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea.The dual-acting dopamine and norepinephrine reuptake inhibitor is approved for narcolepsy in once-daily 75 mg and 150 mg doses, and in obstructive sleep apnea in once-daily 37.5 mg, 75 mg, and 150 mg doses.
Status:
US Approved Rx
(2018)
Source:
NDA210868
(2018)
Source URL:
First approved in 2018
Source:
NDA210868
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Lorlatinib is an investigational medicine that inhibits the anaplastic lymphoma kinase (ALK) and ROS1 proto-oncogene. Lorlatinib was specifically designed to inhibit tumor mutations that drive resistance to other ALK inhibitors. Lorlatinib has in vitro activity against ALK and number of other tyrosine kinase receptor related targets including ROS1, TYK1, FER, FPS, TRKA, TRKB, TRKC, FAK, FAK2, and ACK. Lorlatinib demonstrated in vitro activity against multiple mutant forms of the ALK enzyme, including some mutations detected in tumors at the time of disease progression on crizotinib and other ALK inhibitors. Moreover, lorlatinib possesses the capability to cross the blood-brain barrier, allowing it to reach and treat progressive or worsening brain metastases as well. Lorlatinib is a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) indicated for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on a) the prior use of crizotinib and at least one other ALK inhibitor for metastatic disease, or b) the prior use of alectinib as the first ALK inhibitor therapy for metastatic disease, or c) the prior use of certinib as the first ALK inhibitor therapy for metastatic disease.
Status:
US Approved Rx
(2018)
Source:
NDA211710
(2018)
Source URL:
First approved in 2018
Source:
NDA211710
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Larotrectinib (previously known as ARRY-470 and LOXO-101) is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Larotrectinib is in phase II clinical trials for the treatment patients with solid tumors, non-Hodgkin lymphoma and for the pediatric patients with advanced solid or primary CNS tumors.
Status:
US Approved Rx
(2018)
Source:
NDA210598
(2018)
Source URL:
First approved in 2018
Source:
NDA210598
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Revefenacin (trade name Yupelri is a long-acting muscarinic antagonist developed by Mylan Ireland ltd for the treatment of chronic obstructive pulmonary disease (COPD). It has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation. The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations. In preclinical in vitro as well as in vivo models, prevention of methacholine- and acetylcholine-induced bronchoconstrictive effects was dose-dependent and lasted longer than 24 hours.
Status:
US Approved Rx
(2018)
Source:
NDA210251
(2018)
Source URL:
First approved in 2018
Source:
NDA210251
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Bictegravir is a component of the fixed-dose combination product bictegravir/emtricitabine/tenofovir alafenamide (BIKTARVY®), which received marketing approval for the treatment of human immunodeficiency virus (HIV) infection by the U.S. Food and Drug Administration in February 2018. Bictegravir inhibits the strand transfer activity of HIV-1 integrase, an HIV-1 encoded enzyme that is required for viral replication. Inhibition of integrase prevents the integration of linear HIV-1 DNA into host genomic DNA, blocking the formation of the HIV-1 provirus and propagation of the virus.
Status:
US Approved Rx
(2018)
Source:
NDA209299
(2018)
Source URL:
First approved in 2018
Source:
NDA209299
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Fostamatinib is a pro-drug of a Syk inhibitor R406 initially developed by Rigel Pharmaceuticals, but then in-licensed by AstraZeneca. It reached phase III of clinical trials for such diseases as Rheumatoid Arthritis and Immune Thrombocytopenic Purpura, however, AstraZeneca decided not to proceed with regulatory filings and return the rights to the compound to Rigel Pharmaceuticals. In 2018 the drug was approved by the FDA for treatment of chronic immune thrombocytopenia. Fostamatinib is being developed for Autoimmune Hemolytic Anemia (phase II), graft versus host disease (phase I) and ovarian cancer (phase I).
Status:
US Approved Rx
(2018)
Source:
NDA209627
(2018)
Source URL:
First approved in 2018
Source:
NDA209627
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Segesterone acetate (elcometrine), a progestin, is sold in combination with ethinyl estradiol under the brand name Annovera. Annovera is indicated for use by females of reproductive potential to prevent pregnancy. Segesterone acetate acts as an agonist of the progesterone receptor and it doesn’t possess estrogenic, androgenic, antiandrogenic, or antimineralocorticoid activity.
Status:
US Approved Rx
(2017)
Source:
NDA208854
(2017)
Source URL:
First approved in 2017
Source:
NDA208854
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Naldemedine (Symproic) is an opioid antagonist indicated for the treatment of opioid-induced
constipation (OIC) in adult patients with chronic non-cancer
pain. Naldemedine is an opioid antagonist with binding affinities for mu-, delta-, and kappa-opioid receptors.
Naldemedine functions as a peripherally-acting mu-opioid receptor antagonist in tissues such as the
gastrointestinal tract, thereby decreasing the constipating effects of opioids. Naldemedine is a derivative of naltrexone to which a side chain has been added that increases the molecular
weight and the polar surface area, thereby reducing its ability to cross the blood-brain barrier (BBB).
Naldemedine is also a substrate of the P-glycoprotein (P-gp) efflux transporter. Based on these properties, the
CNS penetration of naldemedine is expected to be negligible at the recommended dose levels, limiting the
potential for interference with centrally-mediated opioid analgesia. Naldemedine was approved in 2017 in both the US and Japan for the treatment of Opioid-induced Constipation.
Status:
US Approved Rx
(2020)
Source:
NDA213227
(2020)
Source URL:
First approved in 2016
Source:
NDA208547
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Dotatate, also known as DOTA-0-Tyr3-Octreotate, is a cyclic 8 amino acid peptide with a covalently bound chelator (dota). The peptide has the amino acid sequence: H-D-Phe-Cys-Tyr-D-Trp-Lys-ThrCys-Thr-OH, and contains one disulfide bond. After radiolabeling with Ga 68 (NETSPOT®) or with Lu 177 (LUTATHERA®), it is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
