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Restrict the search for
methyl aminolevulinate
to a specific field?
Status:
US Approved Rx
(2021)
Source:
NDA214429
(2021)
Source URL:
First approved in 2021
Source:
NDA214429
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Fexinidazole is an antiparasitic drug, which is in the phase III of clinical trial for the treatment of Human African Trypanosomiasis, and in the phase II for the treatment Disease, Chagas and Visceral Leishmaniosis. However, for the Visceral Leishmaniosis, studies were terminated, due to lack of efficacy. Fexinidazole rapidly metabolized to two active metabolites, a sulfone and a sulfoxide, which prolong the pharmacological action of parent drug. These metabolites retaine trypanocidal activity but are less effective in nifurtimox-resistant lines, which can lead to the potential danger in the use of fexinidazole as a monotherapy.
Status:
US Approved Rx
(2021)
Source:
NDA211964
(2021)
Source URL:
First approved in 2021
Source:
NDA211964
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Viloxazine is an antidepressant drug was used to treat patients with depression. Viloxazine inhibits noradrenaline uptake. This drug was approved in some Europe countries, but not in the USA, but then it was discontinued because of competition from other drugs. In the frame of drug repositioning, Viloxazine participated in clinical trials for the treatment of attention deficit hyperactivity disorder. Phase II of trials was successfully passed.
Status:
US Approved Rx
(2021)
Source:
NDA213716
(2021)
Source URL:
First approved in 2021
Source:
NDA213716
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Voclosporin (trans-ISA247) is a Cyclosporin A derivative and immunosuppressive compound currently being investigated for the treatment of psoriasis, lupus nephritis and for the prevention of organ rejection in kidney transplant patients. An animal study showed that a lower blood level of Voclosporin was able to produce a greater or similar inhibition of lymphocyte proliferation, expression of T-cell activation surface antigens, and T-cell cytokine production compared to Cyclosporin A. Voclosporin has been shown to be an efficacious and safe immunosuppressant in phase IIb and phase III trials in renal transplant recipients and in plaque psoriasis patients. In clinical trials, Voclosporin added to standard-of-care induction therapy for lupus nephritis increases complete renal remission (CRR) rates, but higher rates of adverse events including death were observed.
Status:
US Approved Rx
(2020)
Source:
NDA213246
(2020)
Source URL:
First approved in 2020
Source:
NDA213246
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Selpercatinib (LOXO-292, ARRY-192) is a potent and specific RET (c-RET) inhibitor that was granted accelerated FDA approval on May 8, 2020, for specific RET-driven cancer indications. It is currently marketed under the brand name RETEVMO™ by Loxo Oncology Inc.
Status:
US Approved Rx
(2020)
Source:
NDA212295
(2020)
Source URL:
First approved in 2020
Source:
NDA212295
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Remimazolam is an intravenous benzodiazepine sedative-hypnotic with rapid onset and offset of action. This compound undergoes organ-independent metabolism to an inactive metabolite. Like other benzodiazepines, remimazolam can be reversed with flumazenil to rapidly terminate sedation and anesthesia. Phase I and II clinical trials have shown that remimazolam is safe and effective when used for procedural sedation. Phase III clinical trials have been completed investigating efficacy and safety in patients undergoing bronchoscopy and colonoscopy. The developer of this drug has suggested that intensive care unit sedation (beyond 24 hours) could be another possible indication for further development, since it is unlikely that prolonged infusions or higher doses of remimazolam would result in accumulation and extended effect.
Status:
US Approved Rx
(2020)
Source:
NDA209510
(2020)
Source URL:
First approved in 2020
Source:
NDA209510
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Amisulpride, a benzamide derivative, shows a unique therapeutic profile being atypical antipsychotic. At low doses, it enhances dopaminergic neurotransmission by preferentially blocking presynaptic dopamine D2/D3 autoreceptors. At higher doses, amisupride antagonises postsynaptic dopamine D2 and D3 receptors, preferentially in the limbic system rather than the striatum, thereby reducing dopaminergic transmission. In addition its antagonism at serotonin 5-HT7 receptors likely underlies the antidepressant actions. Amisulpride is approved for clinical use in treating schizophrenia in a number of European countries and also for treating dysthymia, a mild form of depression, in Italy.
Status:
US Approved Rx
(2020)
Source:
NDA212950
(2020)
Source URL:
First approved in 2020
Source:
NDA212950
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Temsavir (BMS-626529) is an attachment inhibitor (AI) in clinical development (administered as prodrug BMS-663068) that binds to HIV-1 gp120. Temsavir displays in vitro activity against HIV-1 envelopes with C-C chemokine receptor type 5 (CCR5-), C-X-C chemokine receptor type 4 (CXCR4), and dual tropism. It also is active against almost all HIV-1 subtypes tested except for subtype CRF01-AE and possibly group O. Temsavir can inhibit both CD4-induced and CD4-independent formation of the "open state" four-stranded gp120 bridging sheet, and the subsequent formation and exposure of the chemokine co-receptor binding site. This unique mechanism of action prevents the initial interaction of HIV-1 with the host CD4+ T cell, and subsequent HIV-1 binding and entry. Temsavir is administered as a phosphonooxymethyl ester prodrug (BMS-663068), which was developed to improve the solubility and dissolution of Temsavir. Temsavir is currently being investigated clinically through the use of the prodrug BMS-663068, and a Phase III study of BMS-663068 in HIV-1-infected treatment-experienced subjects is ongoing (NCT02362503).
Status:
US Approved Rx
(2020)
Source:
NDA213591
(2020)
Source URL:
First approved in 2020
Source:
NDA213591
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Capmatinib (INC280, INCB028060), is an orally bioavailable inhibitor of the proto-oncogene c-Met (hepatocyte growth factor receptor [HGFR]) with potential antineoplastic activity. Novartis acquired Incyte's capmatinib, which is in Phase II clinical trial as monotherapy in patients with advanced hepatocellular carcinoma. Capmatinib selectively binds to c-Met, thereby inhibiting c-Met phosphorylation and disrupting c-Met signal transduction pathways. This may induce cell death in tumor cells overexpressing c-Met protein or expressing constitutively activated c-Met protein. c-Met, a receptor tyrosine kinase overexpressed or mutated in many tumor cell types, plays key roles in tumor cell proliferation, survival, invasion, metastasis, and tumor angiogenesis.
Status:
US Approved Rx
(2020)
Source:
NDA210730
(2020)
Source URL:
First approved in 2020
Source:
NDA210730
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
US Approved Rx
(2020)
Source:
NDA214094
(2020)
Source URL:
First approved in 2020
Source:
NDA214094
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
