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The molecule was the first allosteric TYK2 inhibitor to enter clinicaltrials, is the first JAK-family kinase inhibitor approved for psoriasis, and is also the first approved drug targeting a pseudokinase domain. MRTX1133 is currently in Ph I/II trials as an oral agent. #3: LP0200 has completed a Ph.
1] Pimicotinib is under investigation in clinicaltrial NCT05804045 (Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)). 1] Pimicotinib is under investigation in clinicaltrial NCT05804045 (Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)). 6] The U.S. 6] The U.S. .
Orforglipron ( LY-3502970 ) is an oral, non-peptide, small-molecule GLP-1 receptor agonist developed as a weight loss drug by Eli Lilly and Company. [1] then was licensed to Lilly in 2018. [1] then was licensed to Lilly in 2018. [1] then was licensed to Lilly in 2018. [1] kg), on average after 40 weeks. [1]
As the CEO of iOnctura, an innovative oncology biopharmaceutical company she co-founded in 2017, Catherine has played a key role in advancing the development of highly targeted smallmolecules aimed at revolutionising cancer treatment. I also felt that the so-called glass ceiling had disappeared – I felt equal and really enjoyed that.
Unimodality does not allow for mixing data: cell data, images, molecular data, clinical data records, smallmolecule descriptors, ADME Tox data, transcriptomic data, text-based drug and disease representations, clinicaltrial protocols, publications and patent data, etc. Highlighting data integration.
Biohaven acquires exclusive global rights to a portfolio of novel, small-molecule CGRP antagonists.
The lead candidate, HTL0022562, has advanced through preclinical development demonstrating promising and differentiated properties for further investigation in human trials.
Vlad Coric , M.D.,
Smallmolecule candidate Anle138b targets disease modification for multiple system atrophy and other neurological disorders. NYSE and TASE: TEVA) and MODAG GmbH today announced a strategic collaboration on the exclusive worldwide licensing and development of MODAG’s lead compound anle138b and a related compound, sery433.
Although these results cannot prove that there is no possibility of finding a high-affinity smallmolecule binder of NBD1, they are discouraging…” It turns out the smallmolecules they were looking for are not only possible – they were ready for a dedicated team to push them ahead.
Rise of the best-in-class biologics plays: Are you looking to in-license or invest in “de-risked” biology that is already in the clinic? Smallmolecule GLP1s? The incretins as a class also look interesting across a number of follow-on indications, as evidenced by clinicaltrials in these areas (below).
Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Pfizer Inc.
Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.
Notably, over 80% of Bayer’s major global multi-center clinicaltrials now include study sites in China, spanning early-phase development to late-stage pivotal trials. The company currently operates two global research and development (R&D) centers and four world-class production facilities across China.
In the absence of a clinicaltrial result or FDA label to point to, how does one create the case and target product profile (TPP) around a new target? and whether a molecule’s pharmacology can help to mitigate safety risk. Finally, as part of a broader pathway analysis, consider potential implications for selectivity.
In the case of urgent or immediate public interest, process validation may be conducted concurrently with manufacturing the commercial smallmolecule or biologic product to expedite product availability for patients. The quality of data from Stage I validation activities. Prior PPQ knowledge and experience with similar products.
RLY-1971 is a potent smallmolecule inhibitor of Src homology region 2 domain-containing phosphatase-2 (SHP2). RLY-1971 is currently being evaluated in a first-in-human trial designed to treat patients with advanced or metastatic solid tumors. To learn more about the first-in-human clinicaltrial of RLY-1971, please visit here.
Acoltremon AR-15512 CAS 68489-09-8 WeightAverage: 289.419 Monoisotopic: 289.204179113 Chemical FormulaC 18 H 27 NO 2 FDA 2025, 5/28/2025, To treat the signs and symptoms of dry eye disease Tryptyr WS-12 WS 12 (1R,2S,5R)-N-(4-methoxyphenyl)-5-methyl-2-(propan-2-yl)cyclohexane-1-carboxamide Fema No. Archived from the original on 29 May 2025.
1] [2] It is a non- opioid , small-molecule analgesic that works as a selective inhibitor of Na v 1.8 3] History Vertex Pharmaceuticals announced in January 2024 that suzetrigine had successfully met several endpoints in its Phase III clinicaltrials. [5] Suzetrigine CAS 2649467-58-1 Weight Average: 473.4 85 (1): 1119.
“Sebetralstat (KVD900): A Potent and Selective SmallMolecule Plasma Kallikrein Inhibitor Featuring a Novel P1 Group as a Potential Oral On-Demand Treatment for Hereditary Angioedema” Journal of Medicinal Chemistry. Retrieved 9 July 2025 – via Business Wire. October 2022). 65 (20): 13629–13644. doi : 10.1021/acs.jmedchem.2c00921.
SetPoint Medical received FDA Investigational Device Exemption (IDE) approval for a multicenter, double-blind, randomized, sham-controlled pivotal trial that will enroll up to 250 patients at 40 clinicaltrial sites in the U.S. SmallMolecule Inhibitors. Oral, SmallMolecules.
Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and smallmolecules.
Its mission is to develop and license novel therapeutic agents for unmet medical needs against cancer targets such as Globo Series (including Globo H, SSEA-3 and SSEA-4), AKR1C3, and other promising targets. The above poster presentations will be available online at www.obipharma.com on November 23, 2020. About OBI Pharma. OBI Pharma, Inc.,
Berk served as an investigator on several industry-sponsored and cooperative group clinicaltrials, including the pivotal trials for Gleevec® and Avastin®. Inflection Biosciences Ltd is developing smallmolecule therapeutics for the treatment of cancer. About Inflection Biosciences.
Eloxx’s lead investigational product candidate, ELX-02, is a smallmolecule drug candidate designed to restore production of full-length functional proteins. ELX-02 is in the early stages of clinical development focusing on cystic fibrosis.
“Small-molecule factor B inhibitor for the treatment of complement-mediated diseases” Proceedings of the National Academy of Sciences of the United States of America. 1 Factor B is a positive regulator of the alternative complement pathway, where it activates C3 convertase and subsequently C5 convertase. 5 December 2023.
Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021.
The participants in our COVID-19 vaccine clinicaltrial are courageous volunteers who have made a personal and important choice to help make a difference during this pandemic. About the Phase 2/3 Study.
The mAb portfolio is complemented by a non-antibiotic novel mechanism smallmolecule anti-infective candidate being developed to treat lung infections in cystic fibrosis patients. AR-711 is an in-licensed mAb that is directed against the receptor binding domain of the SARS-Cov 2 virus. AR-711 (COVID-19). AR-201 (RSV infection).
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinicaltrials.
Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020. The THRIVE-AA1 Phase 3 trial is a randomized, double-blind, placebo-controlled clinicaltrial of CTP-543 to evaluate hair regrowth using the Severity of Alopecia Tool (SALT) after 24 weeks of dosing in approximately 700 adult patients with moderate to severe alopecia areata.
“We have activated our supply chain, most importantly our site in Belgium, and are starting to manufacture so that our vaccine would be available as soon as possible, if our clinicaltrials prove successful and regulatory approval is granted.”. “As billion doses by the end of 2021.
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. myocarditis and pericarditis. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.
Food and Drug Administration’s Office of Orphan Products Development has granted Orphan Drug Designation to Uttroside-B , a smallmolecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. (OTCQB: QBIO), announced today that the U.S. billion by 2027.
Pfizer and BioNTech are extremely grateful to the study volunteers and investigative site staff in the clinicaltrial program, as their involvement was crucial to today’s important milestone in the companies’ efforts to address the COVID-19 global pandemic. as well as Europe, Latin America, and South Africa. About the Study.
The study is an event-driven trial. Pfizer and BioNTech are committed to decreasing health disparities in underrepresented populations through the clinicaltrial process. Additional enrollment is planned in Germany, Turkey and South Africa.
The positive opinion adopted by the CHMP is based on an evaluation of interim safety and efficacy data from a clinicaltrial of a booster dose of the vaccine in those aged 16 and over, together with published literature and post authorisation data plus real-world evidence from the use of booster doses in young patients in Israel.
The company submitted its Biologic License Application to the FDA which has set a Prescription Drug User Fee Act (PDUFA) date for June 25, 2021. The TransCon technology platform can be applied broadly to proteins, peptides or smallmolecules in multiple therapeutic areas, and can be designed for systemic or localized release.
We believe the target product profiles of our two ophthalmic candidates, Nyxol and APX3330, collectively studied in 18 clinicaltrials and each having market potential, create an opportunity for Ocuphire to become a leading ophthalmic company focused on improving vision and clarity. Cantor Fitzgerald & Co.
The Phase 2/3 trial enrollment to date has exceeded 11,000 participants with a second dose underway. Pfizer and BioNTech are committed to decreasing health disparities in underrepresented populations through the clinicaltrial process.
Clinicaltrial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints.
Pfizer Inc. The data will be discussed with regulatory authorities worldwide. “I
This work may also guide the selection of appropriate participants for clinicaltrials of COVID-19 vaccines, including future human trials using Tonix’s TNX-1800, a live replicating, attenuated COVID-19 vaccine candidate designed to confer durable T cell immunity.”. President and Chief Executive Officer of Tonix Pharmaceuticals.
Primary and all key secondary endpoints including itch, interference of itch on sleep and quality of life were met at Week 16 in two pivotal Phase 3 trials in lebrikizumab clinicaltrial program – Safety profile consistent with prior lebrikizumab studies in atopic dermatitis. ’s Chief Scientific Officer.
“A master protocol to investigate a novel therapy acetyl-L-leucine for three ultra-rare neurodegenerative diseases: Niemann-Pick type C, the GM2 gangliosidoses, and ataxia telangiectasia” Trials. A clinicaltrial to test amlodipine as a new treatment for vascular dementia. 1] It is the L -form of acetylleucine.
gmol 1 3D model ( JSmol ) Interactive image show SMILES show InChI Prete A, Auchus RJ, Ross RJ: Clinical advances in the pharmacotherapy of congenital adrenal hyperplasia. External links “Crinecerfont (Code C174708)” NCI Thesaurus.
Through its existing mRNA production sites in Mainz and Idar-Oberstein, Germany, BioNTech is able to produce mRNA for commercial supply after having already produced the vaccine candidate doses for the clinicaltrials. Once thawed, the vaccine vial can be stored for up to five days at refrigerated (2-8°C) conditions.
Published July 8, 2025 Gwendolyn Wu Senior reporter post share post print email license Proteasomes are cellular machines for breaking down proteins. Specially designed smallmolecule drugs can bring together target proteins with an enzyme that tags them with ubiquitin, thereby marking them for destruction.
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