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Restrict the search for
penicillin g
to a specific field?
Status:
US Approved Rx
(2023)
Source:
NDA214373
(2023)
Source URL:
First approved in 2022
Source:
NADA141566
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Bexagliflozin, also known as EGT1442, is a potent and selective SGLT2 inhibitor. Bexagliflozin is under investigation for the treatment of Type 2 Diabetes Mellitus. Bexagliflozin has been investigated for the treatment of Diabetes Mellitus and Type2 Diabetes Mellitus. Clinical studies have established that bexagliflozin significantly reduces blood glucose and glycated hemoglobin in subjects with diabetes. Treatment with bexagliflozin also induces weight loss and a reduction in systolic and diastolic blood pressure.
Status:
US Approved Rx
(2022)
Source:
NDA214801
(2022)
Source URL:
First approved in 2022
Source:
NDA214801
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Status:
US Approved Rx
(2022)
Source:
NDA214998
(2022)
Source URL:
First approved in 2022
Source:
NDA214998
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
MYK-461 (also known as Mavacamten) is a small-molecule modulator of cardiac myosin that targets the underlying sarcomere hypercontractility of hypertrophic cardiomyopathy, one of the most prevalent heritable cardiovascular disorders. Studies on isolated cells and muscle fibers, as well as intact animals, have shown that MYK-461 inhibits sarcomere force production, thereby reducing cardiac contractility. In Phase II clinical trials MYK-461 reduces left ventricular outflow tract obstruction and improve exercise capacity and symptoms in patients with obstructive hypertrophic cardiomyopathy. Phase III clinical trials are currently ongoing.
Status:
US Approved Rx
(2022)
Source:
NDA213871
(2022)
Source URL:
First approved in 2022
Source:
NDA213871
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
PF-04965842 is an orally administered selective Janus kinase 1 (JAK1) inhibitor. PF-04965842 is currently in clinical trials for the treatment of autoimmune diseases.
Status:
US Approved Rx
(2022)
Source:
NDA215272
(2022)
Source URL:
First approved in 2022
Source:
NDA215272
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Tapinarof (also known as benvitimod, WB-1001; GSK-2894512), an investigational therapeutic aryl hydrocarbon receptor modulating agent that selectively modulates the cytokine cascade deep under the skin, a process that rapidly decreases inflammations and skin plague. Tapinarof participated in clinical trials for the treatment of psoriasis and atopic dermatitis. Phase III clinical trials to evaluate the efficacy and safety of the cream for the topical treatment of plaque psoriasis (psoriasis) was terminated because of the business decision based on the need to prioritize and focus resources within GSK. In July 2018, Roivant subsidiary Dermavant Sciences purchased the rights for tapinarof. Besides, tapinarof participated in phase II clinical trials for patients with atopic dermatitis.
Status:
US Approved Rx
(2022)
Source:
NDA215153
(2022)
Source URL:
First approved in 2022
Source:
NDA215153
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Vonoprazan (Vonoprazan fumarate or TAK-438) under brand name Takecab, discovered by Takeda, is a new medicine for treating acid-related diseases with a novel mechanism of action called potassium-competitive acid blockers (P-CABs) which competitively inhibits the binding of potassium ions to H+,K+-ATPase (also known as the proton pump) in the final step of gastric acid secretion in gastric parietal cells. The drug is approved in Japan for the treatment of acid-related diseases, including gastric ulcer, duodenal ulcer, reflux esophagitis and Adjunct to Helicobacter pylori eradication in the case of Helicobacter pylori gastritis.
Status:
US Approved Rx
(2022)
Source:
NDA215888
(2022)
Source URL:
First approved in 2022
Source:
NDA215888
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Otesaconazole (previously known as VT-1161), an antifungal agent, is an oral inhibitor of fungal lanosterol demethylase (CYP51) but did not inhibit human CYP51. Inhibition of CYP51 results in the accumulation of chemicals known to be toxic to the fungus. CYP51 is the molecular target of the class of drugs referred to as 'azole antifungals'. Mycovia pharmaceuticals initiate enrolment in a phase III trial for the treatment of patients with recurrent vaginal candidiasis (yeast infection). In vitro and in vivo pharmacology studies have demonstrated that the drug is highly active against dermatophytes that cause onychomycosis. Viamet successfully completed phase II clinical trials were was studied the efficacy and safety of oral otesaconazole in patients with onychomycosis of the toenail. In addition, Viamet has completed phase II clinical trial, where was studied the efficacy and safety of otesaconazole in patients with moderate-severe interdigital tinea pedis.
Status:
US Approved Rx
(2023)
Source:
NDA217026
(2023)
Source URL:
First approved in 2022
Source:
NDA217026
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Trofinetide (NNZ 2566), a proprietary small molecule analogue of glycine-proline-glutamate [Glypromate®], is being developed by Neuren Pharmaceuticals for the treatment of brain injuries, fragile X syndrome, Rett syndrome. Trofinetide is a synthetic analogue of a naturally occurring neurotrophic peptide derived from IGF-1, a growth factor produced by brain cells. In animal models, trofinetide exhibits a wide range of important effects including inhibiting neuroinflammation, normalizing the role of microglia and correcting deficits in synaptic function. Trofinetide is being developed both in intravenous and oral formulations for a range of acute and chronic conditions. The intravenous form of trofinetide is presently in a Phase 2 clinical trial in patients with moderate to severe traumatic brain injury. The oral form of trofinetide is in Phase 2 development in Rett syndrome, Fragile X syndrome and mild traumatic brain injury (concussion). Trofinetide has been granted Fast Track Status and Orphan Drug Designation in the U.S. and Orphan Drug Designation in Europe for both Rett syndrome and Fragile X syndrome.
Status:
US Approved Rx
(2022)
Source:
NDA215904
(2022)
Source URL:
First approved in 2022
Source:
NDA215904
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Ganaxolone (3alpha-hydroxy-3beta-methyl-5alpha-pregnan-20-one) (GNX) is the 3beta-methylated synthetic analog of allopregnanolone; it belongs to a class of compounds referred to as neurosteroids. GNX is an allosteric modulator of GABA(A) receptors acting through binding sites which are distinct from the benzodiazepine binding site. It has activity in a broad range of animal models of epilepsy. GNX has been shown to be well tolerated in adults and children. In early phase II studies, GNX has been shown to have activity in adult patients with partial-onset seizures and epileptic children with history of infantile spasms. It is currently undergoing further development in infants with newly diagnosed infantile spasms, in women with catamenial epilepsy, and in adults with refractory partial-onset seizures. Ganaxolone is a CNS-selective GABAA modulator being developed in three different dose forms (IV, capsule, and liquid) intended to maximize therapeutic reach to adult and pediatric patients in both acute and chronic care settings.Ganaxolone is a synthetic analog of endogenous allopregnanolone, which has been shown to be an effective anticonvulsant by restoring electrical balance to the seizing brain. While allopregnanolone’s anticonvulsant and anti-anxiety activities are well documented, allopregnanolone has the potential to convert back to its metabolic precursor progesterone, which could lead to hormonal side effects. Ganaxolone has been designed with an added methyl group that prevents back conversion to an active steroid which unlocks ganaxolone’s potential for chronic use. In preclinical studies, ganaxolone exhibited potency and efficacy comparable to allopregnanolone. Both ganaxolone and allopregnanolone bind to GABAA at the synaptic and extrasynaptic binding sites. Activity with extrasynaptic GABAA receptors are of particular importance for treating patients who developed tolerance to benzodiazepines and barbiturates. Ganaxolone binds to the GABAA receptors, which opens the pore to allow chloride ions to move into the postsynaptic neuron, leading to the inhibition of neurotransmission.
Status:
US Approved Rx
(2022)
Source:
NDA216660
(2022)
Source URL:
First approved in 2022
Source:
NDA216660
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Tauroursodeoxycholic acid (TUDCA) is an endogenous hydrophilic bile acid used clinically to treat certain liver diseases. It is approved in Italy and Turkey for the treatment of cholesterol gallstones and is an investigational drug in China, Unites States, and Italy. Tauroursodeoxycholic acid is being investigated for use in several conditions such as Primary Biliary Cirrhosis (PBC), insulin resistance, amyloidosis, Cystic Fibrosis, Cholestasis, and Amyotrophic Lateral Sclerosis. Tauroursodeoxycholate (TUDC) promote choleresis by triggering the insertion of transport proteins for bile acids into the canalicular and basolateral membranes of hepatocytes. In addition, Tauroursodeoxycholate exerts hepatoprotective and anti-apoptotic effects, can counteract the action of toxic bile acids and reduce endoplasmic reticulum stress. Tauroursodeoxycholate can also initiate the differentiation of multipotent mesenchymal stem cells (MSC) including hepatic stellate cells and promote their development into hepatocyte-like cells. Although the hepatoprotective and choleretic action of TUDC is empirically used in clinical medicine since decades, the underlying molecular mechanisms remained largely unclear.
