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Restrict the search for
methyl aminolevulinate
to a specific field?
Status:
US Previously Marketed
Source:
EXBLIFEP by ALLECRA THERAPS
(2024)
Source URL:
First approved in 2024
Source:
EXBLIFEP by ALLECRA THERAPS
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
US Previously Marketed
Source:
OMLONTI by OCUVEX THERAP
(2022)
Source URL:
First approved in 2022
Source:
OMLONTI by OCUVEX THERAP
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Omidenepag isopropyl, a prodrug, is hydrolyzed in the eye to the active form (Omidenepag) which functions as a selective, nonprostaglandin, prostanoid EP2 agonist, has been developed by Ube Industries and Santen Pharmaceutical as an ophthalmic solution (EYBELIS®) for the treatment of glaucoma and ocular hypertension. Omidenepag isopropyl increases the outfow of aqueous humor via both the uveoscleral outfow and the trabecular outfow pathways, resulting in potent and stable reduction in intraocular pressure (IOP). In September 2018, omidenepag isopropyl ophthalmic solution 0.002% was approved in Japan for the treatment of glaucoma and ocular hypertension. On September 22, 2022, the FDA approved Santen’s Omlonti (omidenepag isopropyl), for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Status:
US Previously Marketed
Source:
EXKIVITY by TAKEDA PHARMS USA
(2021)
Source URL:
First approved in 2021
Source:
EXKIVITY by TAKEDA PHARMS USA
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Mobocertinib (EXKIVITY™) is a first-in-class EGFR tyrosine kinase inhibitor being developed for the treatment of EGFR exon 20 insertion (EGFRex20ins) -positive non-small cell lung cancer (NSCLC). Mobocertinib is a kinase inhibitor of the epidermal growth factor receptor (EGFR) that irreversibly binds to and inhibits EGFR exon 20 insertion mutations at lower concentrations than wild type (WT) EGFR. Two pharmacologically-active metabolites (AP32960 and AP32914) with similar inhibitory
profiles to mobocertinib have been identified in the plasma after oral administration of mobocertinib. In vitro, mobocertinib also inhibited the activity of other EGFR family members (HER2 and HER4) and one additional kinase (BLK) at clinically relevant concentrations (IC50 values <2 nM). Based on efficacy in patients whose disease had progressed on or after platinum-based therapy in a phase I/II trial, mobocertinib was recently granted accelerated approval in the USA in this indication. The drug is also being assessed for marketing approval in various other countries and territories including the EU and China.
Status:
US Previously Marketed
Source:
TRUSELTIQ by HELSINN HLTHCARE
(2021)
Source URL:
First approved in 2021
Source:
TRUSELTIQ by HELSINN HLTHCARE
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Infigratinib (BGJ398), a potent, orally bioavailable, small-molecule pan-FGFR kinase inhibitor. FGFR genetic alterations are the most significant predictors for BGJ398 sensitivity. It is currently in phase 2 trials for Cholangiocarcinoma, Glioblastoma and Solid tumors. Detected adverse events were hyperphosphatemia, fatigue, constipation, cough and nausea. Other adverse events were generally mild and included stomatitis, hair loss, decreased appetite, and fatigue.
Status:
US Previously Marketed
Source:
TRUSELTIQ by HELSINN HLTHCARE
(2021)
Source URL:
First approved in 2021
Source:
TRUSELTIQ by HELSINN HLTHCARE
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Infigratinib (BGJ398), a potent, orally bioavailable, small-molecule pan-FGFR kinase inhibitor. FGFR genetic alterations are the most significant predictors for BGJ398 sensitivity. It is currently in phase 2 trials for Cholangiocarcinoma, Glioblastoma and Solid tumors. Detected adverse events were hyperphosphatemia, fatigue, constipation, cough and nausea. Other adverse events were generally mild and included stomatitis, hair loss, decreased appetite, and fatigue.
Status:
US Previously Marketed
Source:
TRUSELTIQ by HELSINN HLTHCARE
(2021)
Source URL:
First approved in 2021
Source:
TRUSELTIQ by HELSINN HLTHCARE
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Infigratinib (BGJ398), a potent, orally bioavailable, small-molecule pan-FGFR kinase inhibitor. FGFR genetic alterations are the most significant predictors for BGJ398 sensitivity. It is currently in phase 2 trials for Cholangiocarcinoma, Glioblastoma and Solid tumors. Detected adverse events were hyperphosphatemia, fatigue, constipation, cough and nausea. Other adverse events were generally mild and included stomatitis, hair loss, decreased appetite, and fatigue.
