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Restrict the search for
aminolevulinic acid
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There is one exact (name or code) match for aminolevulinic acid
Status:
US Approved Rx
(2016)
Source:
NDA208081
(2016)
Source URL:
First approved in 1995
Source:
ANDA077614
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Aminolevulinic Acid is the first compound in the porphyrin synthesis pathway. The metabolism of aminolevulinic acid (ALA) is the first step in the biochemical
pathway resulting in heme synthesis. Aminolevulinic acid is not a photosensitizer, but rather a
metabolic precursor of protoporphyrin IX (PpIX), which is a photosensitizer. The synthesis of ALA is
normally tightly controlled by feedback inhibition of the enzyme, ALA synthetase, presumably by
intracellular heme levels. ALA, when provided to the cell, bypasses this control point and results in the
accumulation of PpIX, which is converted into heme by ferrochelatase through the addition of iron to the PpIX nucleus. Marketed under the brand name LEVULAN KERASTICK for Topical Solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator, it is indicated for the treatment of minimally to moderately
thick actinic keratoses (Grade 1 or 2, see table 2 for definition) of the face or scalp. Aminolevulinic acid is also being studied in the treatment of other conditions and types of cancer. An orally-administered in vivo diagnostic agent, Aminolevulinic acid, is used in photodynamic diagnosis
(PDD) whose aim is to help doctors visualize the tumor tissue during surgical resection of malignant glioma, it is
already sold in over 20 European countries including Germany and the U.K. According to the presumed mechanism of action, photosensitization following application of aminolevulinic acid (ALA) topical solution occurs through the metabolic conversion of ALA to protoporphyrin IX (PpIX), which accumulates in the skin to which aminolevulinic acid has been applied. When exposed to light of appropriate wavelength and energy, the accumulated PpIX produces a photodynamic reaction, a cytotoxic process dependent upon the simultaneous presence of light and oxygen. The absorption of light results in an excited state of the porphyrin molecule, and subsequent spin transfer from PpIX to molecular oxygen generates singlet oxygen, which can further react to form superoxide and hydroxyl radicals. Photosensitization of actinic (solar) keratosis lesions using aminolevulinic acid, plus illumination with the BLU-UTM Blue Light Photodynamic Therapy Illuminator (BLU-U), is the basis for aminolevulinic acid photodynamic therapy (PDT).
Status:
US Approved Rx
(2016)
Source:
NDA208081
(2016)
Source URL:
First approved in 1995
Source:
ANDA077614
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Aminolevulinic Acid is the first compound in the porphyrin synthesis pathway. The metabolism of aminolevulinic acid (ALA) is the first step in the biochemical
pathway resulting in heme synthesis. Aminolevulinic acid is not a photosensitizer, but rather a
metabolic precursor of protoporphyrin IX (PpIX), which is a photosensitizer. The synthesis of ALA is
normally tightly controlled by feedback inhibition of the enzyme, ALA synthetase, presumably by
intracellular heme levels. ALA, when provided to the cell, bypasses this control point and results in the
accumulation of PpIX, which is converted into heme by ferrochelatase through the addition of iron to the PpIX nucleus. Marketed under the brand name LEVULAN KERASTICK for Topical Solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator, it is indicated for the treatment of minimally to moderately
thick actinic keratoses (Grade 1 or 2, see table 2 for definition) of the face or scalp. Aminolevulinic acid is also being studied in the treatment of other conditions and types of cancer. An orally-administered in vivo diagnostic agent, Aminolevulinic acid, is used in photodynamic diagnosis
(PDD) whose aim is to help doctors visualize the tumor tissue during surgical resection of malignant glioma, it is
already sold in over 20 European countries including Germany and the U.K. According to the presumed mechanism of action, photosensitization following application of aminolevulinic acid (ALA) topical solution occurs through the metabolic conversion of ALA to protoporphyrin IX (PpIX), which accumulates in the skin to which aminolevulinic acid has been applied. When exposed to light of appropriate wavelength and energy, the accumulated PpIX produces a photodynamic reaction, a cytotoxic process dependent upon the simultaneous presence of light and oxygen. The absorption of light results in an excited state of the porphyrin molecule, and subsequent spin transfer from PpIX to molecular oxygen generates singlet oxygen, which can further react to form superoxide and hydroxyl radicals. Photosensitization of actinic (solar) keratosis lesions using aminolevulinic acid, plus illumination with the BLU-UTM Blue Light Photodynamic Therapy Illuminator (BLU-U), is the basis for aminolevulinic acid photodynamic therapy (PDT).
Status:
US Approved Rx
(2024)
Source:
NDA216540
(2024)
Source URL:
First approved in 2024
Source:
NDA216540
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
US Approved Rx
(2024)
Source:
NDA217865
(2024)
Source URL:
First approved in 2024
Source:
NDA217865
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Gavinostat is an orally bioavailable hydroxymate inhibitor of histone deacetylase (HDAC) with potential anti-inflammatory, anti-angiogenic, and antineoplastic activities. Gavinostat inhibits class I and class II HDACs, resulting in an accumulation of highly acetylated histones, followed by the induction of chromatin remodeling and an altered pattern of gene expression. At low, nonapoptotic concentrations, this agent inhibits the production of pro-inflammatory cytokines such as tumor necrosis factor- (TNF-), interleukin-1 (IL-1), IL-6 and interferon-gamma. It is currently in phase 2 trials for Myeloproliferative disorders, Polycythaemia vera and Phase III for Duchenne muscular dystrophy announced. In clinical trials of givinostat as a salvage therapy for advanced Hodgkin's lymphoma, the most common adverse reactions were fatigue, mild diarrhea or abdominal pain, moderate thrombocytopenia, and mild leukopenia.
Status:
US Approved Rx
(2024)
Source:
NDA213972
(2024)
Source URL:
First approved in 2024
Source:
NDA213972
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Sulopenem is a thiolanylthiopenem derivative patented by American multinational pharmaceutical corporation Pfizer Inc as an antibiotic with broad-spectrum antibacterial activity against most gram-positive and gram-negative bacteria. Sulopenem showed concentration-dependent bactericidal activities against Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, and Acinetobacter calcoaceticus. Morphological observation using a phase-contrast microscope revealed that sulopenem induced spherical cell formation with E. coli and K. pneumoniae at lower concentrations and bacteriolysis at higher concentrations. Therapeutic efficacies of sulopenem against systemic infections in mice were almost equal to those of imipenem against Streptococcus pneumoniae.
Status:
US Approved Rx
(2024)
Source:
NDA218037
(2024)
Source URL:
First approved in 2024
Source:
NDA218037
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
US Approved Rx
(2024)
Source:
NDA218784
(2024)
Source URL:
First approved in 2024
Source:
NDA218784
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Vorasidenib (also known as AG 881) was developed as an isocitrate dehydrogenase (IDH) type 1 in the cytoplasm and type 2 in the mitochondria, with potential antineoplastic activity. It is known that IDH is an essential enzyme for cellular respiration in the tricarboxylic acid (TCA) cycle. Isocitrate dehydrogenases 1 and 2 (IDH1/2) are homodimeric enzymes that catalyze the conversion of isocitrate to α-ketoglutarate (α-KG) in the tricarboxylic acid cycle. Vorasidenib participated in phase I clinical trials in patients with advanced hematologic malignancies and in gliomas.
Status:
US Approved Rx
(2024)
Source:
NDA218860
(2024)
Source URL:
First approved in 2024
Source:
NDA218860
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Elafibranor (GFT505) is an agonist of the peroxisome proliferator-activated receptor-α and peroxisome proliferator-activated receptor-δ. GFT505 has an active
metabolite, GFT1007, and both have potent agonist activity
for PPAR-a and to a lesser extent for PPAR-d. Elafibranor improves insulin sensitivity, glucose homeostasis, and lipid metabolism and reduces inflammation. Elafibranor (GFT505) reverses nonalcoholic steatohepatitis (NASH) to prevent fibrosis progression. With an outstanding safety and tolerance profile, elafibranor provides NASH patients with needed cardio-protective benefits. Elafibranor is currently being evaluated in the clinical Phase 3 study RESOLVE-IT. The safety profile of GFT505 from the completed clinical
trials appears satisfactory with no indication of PPAR-g agonist
effects such as edema or body weight gain.
Status:
US Approved Rx
(2024)
Source:
NDA217202
(2024)
Source URL:
First approved in 2024
Source:
NDA217202
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Landiolol (Onoact) is an intravenously administered, ultra short-acting β1-blocker with an elimination half-life of 3-4 min and ≈8-fold greater cardioselectivity than esmolol in vitro. It is approved in Japan for the treatment of intraoperative and postoperative tachyarrhythmias, but in clinical practice is also used to prevent postoperative tachyarrhythmias, such as atrial fibrillation after coronary artery bypass grafting. Randomized controlled trials in patients undergoing open-heart surgery demonstrated that various dosages of landiolol (0.0005-0.04 mg/kg/min) [0.5-40 μg/kg/min] were more effective than diltiazem in converting postoperative atrial fibrillation to normal sinus rhythm during the first 8 h after surgery, and were more effective than placebo (or no landiolol) in preventing the development of atrial fibrillation during the first week after surgery (primary efficacy endpoints). Landiolol was generally well tolerated in clinical trials, with a relatively low risk of hypotension and bradycardia, although routine monitoring of cardiac function during landiolol administration is important. In general, adverse events such as reduced blood pressure resolve quickly after discontinuation of landiolol. Thus, as an ultra short-acting β1-blocker with a rapid onset of action and readily titratable and rapidly reversible effects, landiolol represents an important agent for the management of intraoperative and postoperative tachyarrhythmias.
Status:
US Approved Rx
(2024)
Source:
NDA217899
(2024)
Source URL:
First approved in 2024
Source:
NDA217899
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
MBX-8025 (Seladelpar) is an agonist of peroxisome proliferator-activated receptor delta. MBX-8025 improves insulin sensitivity and reverses dyslipidemia and hepatic storage of lipotoxic lipids to improve nonalcoholic steatohepatitis pathology in atherogenic diet-fed obese diabetic mice. MBX-8025 improves lipoprotein subfractions associated with atherogenic dyslipidemia. CymaBay Therapeutics is developing MBX-8025 for the treatment of patients with the autoimmune liver disease, primary biliary cholangitis and nonalcoholic steatohepatitis.
Status:
US Approved Rx
(2023)
Source:
NDA216873
(2023)
Source URL:
First approved in 2023
Source:
NDA216873
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Momelotinib (CYT387) is an ATP-competitive small molecule that potently inhibits JAK1/JAK2 kinases. Momelotinib is developing by Gilead Sciences for the oral treatment of pancreatic and non-small cell lung cancers, and myeloproliferative disorders (including myelofibrosis, essential thrombocythaemia and polycythaemia vera).
