A PHASE 1, OPEN LABEL, FIXED SEQUENCE STUDY TO ESTIMATE THE EFFECT OF MULTIPLE DOSE PF-06650833 ON THE PHARMACOKINETICS OF SINGLE DOSE ORAL CONTRACEPTIVE STEROIDS IN HEALTHY FEMALE PARTICIPANTS

This is a Phase 1, open label, fixed sequence study of the effect of multiple dose PF-06650833 on single dose OC PK in healthy female subjects.

Start Date08 Oct 2021

Sponsor / Collaborator

Pfizer Inc.

NCT04933799 / Unknown statusPhase 2IIT

A Randomized , Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Trial Assessing the Efficacy and Safety of PF-06650833 in Hospitalized Patients With COVID-19 Pneumonia and Exuberant Inflammation.

The aim of the current clinical study is to evaluate the efficacy and safety of inhibition of Interleukin-1 receptor associated kinase 4 (IRAK4) in ameliorating the proinflammatory state and improving outcomes in severe COVID-19.

Start Date06 Jan 2021

Sponsor / Collaborator

Bronx-Lebanon Hospital Center Health Care System

[+1]

NCT04575610 / TerminatedPhase 2IIT

Investigation of IRAK4 Inhibition to Mitigate the Impact of COVID-19 in Severe SARS-CoV-2 (I-RAMIC)

The purpose of this study is to assess the efficacy of PF-06650833 in addition to standard-of-care compared to standard-of-care treatment alone in improving outcomes in patients with COVID-19.

Start Date27 Nov 2020

Sponsor / Collaborator

Yale University

[+1]

100 Clinical Results associated with Zimlovisertib

100 Translational Medicine associated with Zimlovisertib

100 Patents (Medical) associated with Zimlovisertib

Literatures (Medical) associated with Zimlovisertib

01 Jul 2024·EXPERIMENTAL NEUROLOGY

Inhibiting the IRAK4/NF-κB/NLRP3 signaling pathway can reduce pyroptosis in hippocampal neurons and seizure episodes in epilepsy

Article

Author: Cui, Xiaoxiao ; Li, Lei ; Zhang, Xuefei ; Han, Xiong ; Zhao, Ting ; Chen, Yanan ; Cao, Jing ; Sun, Lei ; Wang, Na ; Zhang, Jiewen ; Su, Songxue ; Zhao, Jianyuan

BACKGROUND:

Interleukin-1 receptor-associated kinase 4 (IRAK4) plays an important role in immune modulation in various central nervous system disorders. However, IRAK4 has not been reported in epilepsy models in animal and clinical studies, nor has its involvement in regulating pyroptosis in epilepsy.

METHOD:

First, we performed transcriptome sequencing, quantitative real-time polymerase chain reaction, and western blot analysis on the hippocampal tissues of refractory epilepsy patients to measure the mRNA and protein levels of IRAK4 and pyroptosis-related proteins. Second, we successfully established a pentylenetetrazol (PTZ)-induced seizure mouse model. We conducted behavioral tests, electroencephalography, virus injection, and molecular biology experiments to investigate the role of IRAK4 in seizure activity regulation.

RESULTS:

IRAK4 is upregulated in the hippocampus of epilepsy patients and PTZ-induced seizure model mice. IRAK4 expression is observed in the hilar neurons of PTZ-induced mice. Knocking down IRAK4 in PTZ-induced mice downregulated pyroptosis-related protein expression and alleviated seizure activity. Overexpressing IRAK4 in naive mice upregulated pyroptosis-related protein expression and increased PTZ-induced abnormal neuronal discharges. IRAK4 and NF-κB were found to bind to each other in patient hippocampal tissue samples. Pyrrolidine dithiocarbamate reversed the pyroptosis-related protein expression increase caused by PTZ. PF-06650833 alleviated seizure activity and inhibited pyroptosis in PTZ-induced seizure mice.

CONCLUSION:

IRAK4 plays a key role in the pathological process of epilepsy, and its potential mechanism may be related to pyroptosis mediated by the NF-κB/NLRP3 signaling pathway. PF-06650833 has potential as a therapeutic agent for alleviating epilepsy.

27 Feb 2024·NEJM evidence

Brepocitinib, Zimlovisertib, and Ropsacitinib in Hidradenitis Suppurativa

Article

Author: Banfield, Christopher ; Khattri, Saakshi ; Kimball, Alexa B. ; Peeva, Elena ; Oemar, Barry ; Ghosh, Pranab ; Moiin, Ali ; Mangold, Aaron R. ; Porter, Martina L. ; Forman, Seth

BACKGROUND: Hidradenitis suppurativa (HS) is a debilitating, inflammatory skin disease with limited treatment options and partially understood pathophysiology. Using an umbrella trial design, three kinase inhibitor immunomodulators with different mechanisms of action were evaluated. METHODS: This phase 2a, double-blind, parallel-group trial enrolled adults with moderate to severe HS who were then randomly assigned (1:1:1:1) to once-daily brepocitinib 45 mg (a JAK1/TYK2 inhibitor), zimlovisertib 400 mg (an IRAK4 inhibitor), ropsacitinib 400 mg (a TYK2 inhibitor), or matching placebo for 16 weeks. The primary end point was the percentage of participants achieving HS clinical response (HiSCR) at week 16. Safety, including treatment-emergent adverse events (TEAEs), was monitored throughout. RESULTS: Totals of 52, 47, 47, and 48 participants were assigned to brepocitinib, zimlovisertib, ropsacitinib, and placebo, respectively. At week 16, 28% were lost to follow-up and assumed to be nonresponders; HiSCR occurred in 33.3% (16/48) of participants receiving placebo and in 51.9% (27/52), 34.0% (16/47), and 37.0% (17/46) of those receiving brepocitinib, zimlovisertib, and ropsacitinib (difference in percentage points vs. placebo [90% confidence interval], 18.7 [2.7 to 34.6], 0.7 [−15.2 to 16.7], and 3.5 [−12.6 to 19.6]), respectively. TEAEs occurred more frequently with active treatment (brepocitinib, 30 [57.7%]; zimlovisertib, 26 [55.3%]; ropsacitinib, 29 [61.7%]; placebo, 23 [47.9%]). Most TEAEs (infections, skin disorders, and gastrointestinal symptoms) were mild; there were no deaths. CONCLUSIONS: Participants with moderate to severe HS treated with brepocitinib experienced greater clinical response, whereas those on zimlovisertib and ropsacitinib did not, compared with placebo. These results favor the JAK/STAT pathway as an immunologic target in HS and did not confirm a role for selective IRAK4 or TYK2 inhibition. These results should be confirmed in larger studies with longer follow-up. (Funded by Pfizer; ClinicalTrials.gov registration number, NCT04092452.)

01 Jan 2024·Small (Weinheim an der Bergstrasse, Germany)

Targeted Nanocarriers for Systemic Delivery of IRAK4 Inhibitors to Inflamed Tissues

Article

Author: Taratula, Olena R. ; Park, Youngrong ; Marks, Daniel L. ; Taratula, Oleh ; Korzun, Tetiana ; Avila, Uriel ; Sabei, Fahad Y. ; Sharma, Kongbrailatpam Shitaljit ; Raitmayr, Constanze J. ; Demessie, Ananiya A. ; Moses, Abraham S. ; Singh, Prem ; Levasseur, Peter R. ; Morgan, Terry

Abstract:

Persistent and uncontrolled inflammation is the root cause of various debilitating diseases. Given that interleukin‐1 receptor‐associated kinase 4 (IRAK4) is a critical modulator of inflammation, inhibition of its activity with selective drug molecules (IRAK4 inhibitors) represents a promising therapeutic strategy for inflammatory disorders. To exploit the full potential of this treatment approach, drug carriers for efficient delivery of IRAK4 inhibitors to inflamed tissues are essential. Herein, the first nanoparticle‐based platform for the targeted systemic delivery of a clinically tested IRAK4 inhibitor, PF‐06650833, with limited aqueous solubility (57 µg mL−1) is presented. The developed nanocarriers increase the intrinsic aqueous dispersibility of this IRAK4 inhibitor by 40 times. A targeting peptide on the surface of nanocarriers significantly enhances their accumulation after intravenous injection in inflamed tissues of mice with induced paw edema and ulcerative colitis when compared to non‐targeted counterparts. The delivered IRAK4 inhibitor markedly abates inflammation and dramatically suppresses paw edema, mitigates colitis symptoms, and reduces proinflammatory cytokine levels in the affected tissues. Importantly, repeated injections of IRAK4 inhibitor‐loaded nanocarriers have no acute toxic effect on major organs of mice. Therefore, the developed nanocarriers have the potential to significantly improve the therapeutic efficacy of IRAK4 inhibitors for different inflammatory diseases.

News (Medical) associated with Zimlovisertib

31 Jan 2023

·www.fiercebiotech.com

Pfizer punts pair of orphan drugs amid rare disease R&D rethink

Pfizer is kicking recifercept to the curb along with PF-06755347, a recombinant Fc fusion protein. Pfizer, amid a rethink of its rare disease R&D strategy, has punted (PDF) a pair of orphan drug candidates from its clinical development pipeline in a cull that also narrowed the opportunities open to the near-approval JAK3/TEC inhibitor ritlecitinib. Recifercept is the most advanced rare disease candidate to become surplus to requirements in the latest pipeline update. The molecule is designed to bind to fibroblast growth factor isoforms and thereby act as a decoy that reduces FGFR3 signaling. Seeing that FGFR3 mutations drive inhibitory signaling in the rare disease achondroplasia, Pfizer made the condition its focus indication for recifercept development. The program looked to be on track late last year, when Pfizer began a pilot project to check the feasibility of constructing a concurrent external control for recifercept, but has now hit the skids. The termination of development comes weeks after Pfizer wrapped up a phase 2 trial of the long-term safety and efficacy of recifercept. Pfizer is kicking the candidate to the curb along with PF-06755347, a recombinant Fc fusion protein that is the product of a licensing agreement the Big Pharma formed with Gliknik in 2013. Gliknik received $15 million from Pfizer when the candidate entered phase 1 four years ago. PF-06755347 was in development as a treatment for primary immune thrombocytopenia and chronic inflammatory demyelinating polyneuropathy, an indication in which it has orphan drug status in the U.S. Away from rare diseases, Pfizer dropped a midphase rheumatoid arthritis candidate, ritlecitinib, and a trio of phase 2 cancer programs. Ritlecitinib is closing in on approval decisions in alopecia areata on both sides of the Atlantic and is in phase 2 and 3 development as a treatment for vitiligo, ulcerative colitis and Crohn’s disease. But after studying the candidate with the IRAK4 inhibitor zimlovisertib and JAK inhibitor Xeljanz, Pfizer has decided to abandon plans to develop it as a treatment for rheumatoid arthritis. The three early-phase cancer candidates that failed to make the cut at Pfizer are: the therapeutic vaccine PF-07263689 in solid tumors; the BRAF kinase inhibitor PF-07284890 in melanoma; and the CDK2/4/6 inhibitor PF‑06873600 in metastatic breast cancer. Pfizer's discontinuation drive also included ending phase 3 trials for the company's blockbuster COVID-19 pill Paxlovid in standard risk populations and as a prophylactic treatment. The antiviral is already authorized in high risk populations but had flopped in a post-exposure trial.

Phase 2License out/inOrphan DrugVaccinePhase 3

09 Jan 2023

·www.prnewswire.com

Rheumatoid Arthritis Market is Expected to Showcase Significant Growth in the 7MM at a Minimal CAGR of 1.9% During the Study Period (2019-2032), Predicts DelveInsight

The dynamics of the rheumatoid arthritis market are anticipated to change in the coming years owing to the increasing awareness and expected increase in investment in the R&D activities. Companies like GlaxoSmithKline [Otilimab (MOR103/GSK3196165)], Taisho Pharmaceutical [Ozoralizumab (TS-152)], Aclaris Therapeutics [Zunsemetinib (ATI-450)], Abivax [ABX464], and others with their key candidates are in the late clinical and filing stage. LAS VEGAS, Jan. 9, 2023 /PRNewswire/ -- DelveInsight's Rheumatoid Arthritis Market Insights report includes a comprehensive understanding of current treatment practices, rheumatoid arthritis emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into the 7MM [the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Rheumatoid Arthritis Market Report As per DelveInsight analysis, the rheumatoid arthritis market size in the 7MM was approximately USD 27 billion in 2021. According to the assessment done by DelveInsight, the estimated total rheumatoid arthritis prevalent population in the 7MM was approximately 4. 7 million in 2021. Leading rheumatoid arthritis companies such as Taisho Pharmaceuticals, R-Pharm, GlaxoSmithKline, Aclaris Therapeutics, Pfizer, Abivax, Bristol Myers Squibb, Oscotec/Genosco, Mesoblast, Pfizer Akros Pharma/Japan Tobacco, Abbvie, Horizon Therapeutics, Eli Lilly and Company, Taiho Pharmaceutical, Gilead Sciences, Kiniksa Pharmaceuticals, Istesso, SynAct Pharma, Cyxone, and others are developing novel rheumatoid arthritis drugs that can be available in the rheumatoid arthritis market in the coming years. The promising rheumatoid arthritis therapies in the pipeline include Ozoralizumab (TS-152), Artlegia (Olokizumab), Otilimab (GSK3196165/MOR103), Zunsemetinib (ATI-450), Ritlecitinib (PF-06651600), ABX464, Branebrutinib, Cevidoplenib (SKI-O-703), MPC-300-IV, PF-06650833, JTE -051, ABBV-154, TAS5315, MBS2320, AMT-101, AP1189, Rabeximod (Rob 803), and others. In June 2022, Cyxone received a response from a Type B Pre-IND meeting with the US FDA. The response from the FDA facilitates Cyxone to continue planning the Phase IIb study with Rabeximod in RA. In December 2021, Taisho Pharmaceuticals presented the interim results from a 24-week administration in Phase II/III clinical trial (OHZORA study) of ozoralizumab in adult patients with RA at the annual meeting of the Japanese Society for Clinical Rheumatology and Related Research. Discover which therapies are expected to grab the major rheumatoid arthritis market share @ Rheumatoid Arthritis Market Report Rheumatoid Arthritis Overview Rheumatoid arthritis is a type of autoimmune disease. It happens when our immune system, which is supposed to defend us, malfunctions and starts attacking our own tissues. It causes inflammation in the joint lining (the synovium). As a result, joints may become red, warm, swollen, and painful, which are all symptoms of rheumatoid arthritis. The precise causes of rheumatoid arthritis are still unknown. Because the early signs and symptoms of rheumatoid arthritis are similar to those of many other diseases, it can be difficult to detect in its early stages. There is no single blood test or physical finding that can confirm the diagnosis of rheumatoid arthritis. There is no known cure for rheumatoid arthritis. However, clinical trials of rheumatoid arthritis show that remission of symptoms is more common when rheumatoid arthritis treatment with disease-modifying antirheumatic medicines begins early (DMARDs). Rheumatoid Arthritis Epidemiology Segmentation DelveInsight estimates that there were approximately 4.7 million prevalent cases of rheumatoid arthritis in the 7MM in 2021. Among the EU4 and the UK countries, Germany accounted for the highest number of rheumatoid arthritis cases, whereas France accounted for the lowest cases in 2021 The rheumatoid arthritis market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Prevalent Cases Total Diagnosed Prevalent Cases Gender-specific Prevalent Cases Age-specific Prevalent Cases Severity-specific Prevalent Cases Patients on Targeted Therapies Line-Wise Treated Cases Download the report to understand which factors are driving rheumatoid arthritis epidemiology trends @ Rheumatoid Arthritis Epidemiological Insights Rheumatoid Arthritis Treatment Market Over the last few years, there has been a dramatic improvement in rheumatoid arthritis outcomes as a direct result of paradigm shifts in rheumatoid arthritis treatment. At the moment, the main rheumatoid arthritis treatment options are Medicine (for long-term relief of symptoms and slowing the progression of the condition), Supportive treatments (including physiotherapy and occupational therapy, to help keep the patient mobile and manage any problems related to daily activities), and Surgery (to correct any joint problems that develop over a period of time). Nonsteroidal anti-inflammatory drugs (NSAIDs) are typically used only for symptomatic treatment until a rheumatoid arthritis diagnosis is established because they reduce pain and stiffness in patients but have no effect on disease progression. Moreover, disease-modifying antirheumatic drugs (DMARDs) are used to target inflammation and prevent further joint damage and disease progression. DMARDs are a class of drugs that have been shown to affect the underlying cause of rheumatoid arthritis by reducing immune system overactivity, thereby alleviating pain, swelling, and stiffness and preventing joint changes. DMARDs can be prescribed singly or in combination as an initial part of treatment. Methotrexate is the first-line DMARD agent for the majority of rheumatoid arthritis patients. It has a relatively quick onset of action at therapeutic doses (6-8 weeks), good efficacy, a low toxicity profile, is easy to administer, and is relatively inexpensive. To know more about rheumatoid arthritis guidelines, visit @ Rheumatoid Arthritis Management Rheumatoid Arthritis Pipeline Therapies and Key Companies Artlegia (Olokizumab): R-Pharm TS-152 (Ozoralizumab): Taisho Pharmaceuticals Otilimab (GSK3196165/MOR103): GlaxoSmithKline ATI-450 (Zunsemetinib/CDD-450): Aclaris Therapeutics Branebrutinib: Bristol Myers Squibb LY3462817: Eli Lilly and Company TAS5315: Taiho Pharmaceutical Rabeximod (Rob 803): Cyxone GS-5718: Gilead Sciences KPL-404: Kiniksa Pharmaceuticals MBS2320: Istesso AMT-101: Applied Molecular Transport Dazodalibep (HZN-4920): Horizon Therapeutics Cevidoplenib (SKI-O-703): Genosco/Oscotec HB-AdMSCs: Hope Biosciences ABX464: Abivax MPC-300-IV: Mesoblast PF-06650833: Pfizer JTE 051: Akros Pharma/Japan Tobacco Dekavil (F8IL10): Pfizer/Philogen ABBV-154: AbbVie PF-06651600 (Ritlecitinib): Pfizer AP1189: SynAct Pharma Learn more about the FDA-approved drugs for rheumatoid arthritis @ Drugs for Rheumatoid Arthritis Treatment Rheumatoid Arthritis Market Dynamics The dynamics of the rheumatoid arthritis market is anticipated to change in the future due to the increasing awareness and expected increase in investment in the R&D activities by the leading companies working in the rheumatoid arthritis market space. Moreover, current therapies, such as biological DMARDs, have shown promising results in treating rheumatoid arthritis patients, and market penetration is expected to increase in the future, driving rheumatoid arthritis market growth. Furthermore, there is still a high demand for therapies with a similar efficacy profile to current therapies but a better safety profile and a more patient-friendly RoA. Oral classes, such as JAKi and the upcoming BTKi, are expected to contribute to the rheumatoid arthritis market growth due to patient-friendly RoA. However, several factors are likely to hamper the rheumatoid arthritis market growth. The rheumatoid arthritis market is highly competitive, and new entrants are expected to face some resistance and low uptake because anti-TNFs currently dominate the rheumatoid arthritis market, and the entry of biosimilars will pose significant challenges to new and upcoming treatment options in the rheumatoid arthritis market. In addition, the entry of biosimilars has already begun in the US and EU (i.e., Remicade biosimilars), and as a result, sales value has started to decline. The impact will be more pronounced when biosimilars/ generics of some blockbuster drugs, such as Humira (i.e., 2023 in the US), Xeljanz (i.e., 2025 in the US), will enter the rheumatoid arthritis market, and this will significantly impact the growth of the rheumatoid arthritis market. Scope of the Rheumatoid Arthritis Market Report Therapeutic Assessment: Rheumatoid Arthritis current marketed and emerging therapies Rheumatoid Arthritis Market Dynamics: Rheumatoid Arthritis market drivers and barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Unmet Needs, KOL's views, Analyst's views, Rheumatoid Arthritis Market Access and Reimbursement Discover more about rheumatoid arthritis drugs in development @ Rheumatoid Arthritis Clinical Trials Table of Contents Related Reports Rheumatoid Arthritis Epidemiology Forecast Rheumatoid Arthritis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted rheumatoid arthritis epidemiology in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Juvenile Rheumatoid Arthritis Pipeline Juvenile Rheumatoid Arthritis Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products and the key juvenile rheumatoid arthritis companies, including Novartis, AbbVie, Eli Lilly and Company, Sanofi, among others. Juvenile Rheumatoid Arthritis Market Juvenile Rheumatoid Arthritis Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key juvenile rheumatoid arthritis companies, including Novartis, AbbVie, Eli Lilly and Company, Sanofi, among others. Psoriatic Arthritis Pipeline Psoriatic Arthritis Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key psoriatic arthritis companies, including Mylan, Celltrion, Pfizer, Amgen, among others. Psoriatic Arthritis Market Psoriatic Arthritis Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key psoriatic arthritis companies, including Mylan, Celltrion, Pfizer, Amgen, among others. Other Trending Reports Tay-sachs Disease Or Gm2 Gangliosidosis Market | Onycholysis Market | Diagnostic Imaging Equipment Market | Chemotherapy-induced Peripheral Neuropathy Market | Global Electrophysiology Devices Market | Anaphylaxis Market | Atherectomy Devices Market | Helicobacter Pylori Infections Market | Ophthalmic Imaging Equipment Market | Androgenetic Alopecia Market | Allergic Rhinitis Market | Chronic Inflammatory Demyelinating Polyneuropathy Market | Chronic Inflammtory Demyelinating Polyneuropathy Market | Colorectal Cancer Crc Market | Opioid Induced Constipation Market | Vertigo Market | Bone Anchored Hearing Systems Market | Wound Closure Devices Market | Hip Replacement Devices Market | Hemodynamic Monitoring Systems Market | Egfr Non-small Cell Lung Cancer Market | Helicobacter Pylori Infection Market | Hyperkalemia Market | Polycythemia Market Neurostimulation Devices Market | Carpal Tunnel Syndrome Market | Ventilator Market | Cerebral Aneurysm Market | Alpha Antitrypsin Market | Binge Eating Disorder Market | Bunion Market | Concussions Market Size | Exocrine Pancreatic Insufficiency Market | Healthcare Due Diligence Services | Minimal Residual Disease Market Related Healthcare Blogs Rheumatoid Arthritis Emerging Drugs Knee Osteoarthritis Pipeline Rheumatoid Arthritis Market Scenario Juvenile Idiopathic Arthritis Therapy Market Related Healthcare Services Healthcare Business Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Additionally, get in touch with our business executive to explore @ Healthcare Due Diligence Services Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Clinical Result

08 Nov 2022

·www.prnewswire.com

Extremely Robust COVID-19 Clinical Trial Pipeline With 420+ Key Companies Expected to Change the Pace of the COVID-19 Treatment

COVID-19 clinical trial pipeline constitutes 420+ key companies continuously working towards developing 520+ COVID-19 vaccines and drugs, analyzes DelveInsight LAS VEGAS, Nov. 8, 2022 /PRNewswire/ -- DelveInsight's ' COVID-19 Competitive Landscape – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline COVID-19 vaccines in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the COVID-19 competitive domain. Key Takeaways from the COVID-19 Pipeline Report Over 420+ COVID-19 companies are evaluating 520+ COVID-19 pipeline therapies in various stages of development, and their anticipated acceptance in the COVID-19 market would significantly increase market revenue. Leading COVID-19 companies such as Westvac Biopharma, Xenothera, Windtree Therapeutics, Vir Biotechnology, ViiV Healthcare, Verastem, VBL Therapeutics, Vasomune Therapeutics, Inc., Valneva, Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories, UNION Therapeutics, Trustem, Toscana Life Sciences, Throne Biotechnologies, Thirty respiratory Limited, Theravance Biopharma, TC BioPharm, Syntax for Science, S.L, SyneuRx, Swedish Orphan Biovitrum, Swedish Herbal Institute AB, Stemedica Cell Technologies, Staidson (Beijing) Biopharmaceuticals Co., Ltd, Sound Pharmaceuticals, Sorrento Therapeutics, SolAeroMed, SK Bioscience, Sinovac Biotech Co., Ltd, Sinocelltech, Shenzhen Kangtai Biological Products Co., Ltd., Shaperon, Senhwa Biosciences, Inc., Selva Therapeutics, Archivel Farma, R-Pharm, Rohto Pharmaceutical, Revimmune, Resverlogix Corporation, Restorbio, Resolve Therapeutics, Renibus Therapeutics, ReiThera, Regeneron Pharmaceuticals, RedHill Biopharma, Red de Terapia Celular, Reata Pharmaceuticals, Inc., Qurient Co, Quercis Pharma, PureTech, Pulmotect, PTC Therapeutics, Pluristem Ltd., Pliant Therapeutics, Pharming Technologies B.V., Pharmenterprises, Pharmamel S.L., Pharma Holdings, Pharco Pharmaceuticals, Pfizer, Petrovax, Paion UK Ltd., Ashvattha Therapeutics, Inc. (Orpheris), OPKO Health, Oncotelic Inc., National Resilience, Inc. (Ology Bioservices), Olatec Therapeutics LLC, Novavax, Novartis Pharmaceuticals, Notitia Biotechnologies Company, Noorik Biopharmaceuticals, Nobelpharma, Moderna, Moderna, MetrioPharm, Merck Sharp & Dohme Corp., Merck KGaA, Medicago Inc., Mallinckrodt, Mabwell (Shanghai) Bioscience Co., Ltd., Lifefactors Zona Franca, Leading BioSciences, Kiniksa Pharmaceuticals, Ltd., 3M, 4D Pharma, AbbVie, Apotex, AgelessRx, AgenTus Therapeutics, AiCuris, AlloVir, Apeiron Biologics, Bausch Health Americas, BeiGene, Biotest, Bio-Thera Solutions, Cadila Healthcare Limited, Cellenkos, Cellularity Incorporated, Chiesi Farmaceutici S.p.A., Clene Nanomedicine, Codagenix, Debiopharm, Direct Biologics, Eiger BioPharmaceuticals, Emergent Biosolutions, Enlivex Therapeutics, Evergreen Therapeutics, Faron Pharmaceuticals, Frontier Biotechnologies, FSD Pharma, Genentech, Inc., Globavir Biosciences, Grand Medical, Grifols Therapeutics LLC, Inotrem, Ionis Pharmaceuticals, Jazz Pharmaceuticals, Kamada, Kiadis Pharma, Medicine Invention, MedRegen LLC, Miltenyi Biomedicine, Natureceuticals Sdn Bhd, NeoImmune Tech, Neutrolis, Ology Bioservices, Oncovir, OPKO Health, Organicell Regenerative Medicine, and others are evaluating novel drugs for COVID-19 to improve the treatment landscape. Key COVID-19 pipeline therapies in various stages of development include XAV-19, Sinapultide, VIR-7831, Maraviroc, Duvelisib, VB 201, AV-001, VLA2001, T3 solution for injection, UNIKINON, UNI911, Umbilical cord derived mesenchymal stem cells, MAD0004J08, Stem Cell Educator therapy, RESP301, TD-0903, TCB008, Bemiparin, Pentarlandir™ UPPTA, Emapalumab, Kan Jang capsules, hMSC, BDB-001, Ebselen, COVI-DROPS| Placebo, STI-5656, COVI-AMG, PSC-04, S-1226, GBP510, SARS-COV-2 inactivated vaccine, SCTA01, SARS-CoV-2 Vaccine (Vero Cells), Inactivated, NuSepin, Silmitasertib, SLV213, RUTI® vaccine, Olokizumab + RPH-104, Mesenchymal stem cell (ADR-001), CYT107, Apabetalone, RTB101, RSLV-132, RBT-9, GRAd-COV2, REGN-COV2 Antibody Cocktail, ABC 294640, Upamostat, Mesenchymal Stromal Cells, Bardoxolone methyl, Telacebec, IQC-950AN, LYT-100, PUL-042, PTC-299, PLX-PAD, PLN-74809, Conestat alfa, Treamid, Melatonin, LTX-109, Selenium, Ramipril, PF-06650833, Polyoxidonium, Remimazolam, OP-101, Rayaldee, OT-101, ADM03820, OLT 1177, NVXCoV 2373, DFV890, Crizanlizumab, MAS-825, NBT-NM108, Ambrisentan, Sargramostim, Gam-COVID-Vac, mRNA-1283, mRNA-1273, MP1032, Molnupiravir, M5049, Covifenz, INOmax, MW33, COVID-19 convalescent plasma, LB1148, Mavrilimumab, and others. In October 2022, eFFECTOR Therapeutics announced the completion of enrollment for the second cohort of a three-cohort Phase Ib clinical trial of zotatifin in non-hospitalized adults with confirmed COVID-19 infection. In October 2022, Pfizer/BioNTech and Moderna's bivalent COVID-19 booster vaccines targeting the BA.4 and BA.5 subvariants of Omicron have been approved for use in children and adolescents in the United States. In October 2022, an intranasal formulation of AstraZeneca's widely used COVID-19 vaccine, Vaxzevria, failed at the first hurdle, with results from a phase I trial revealing that it was unable to stimulate a strong immune response to the virus. In September 2022, Bharat Biotech's Covid-19 vaccine candidate codenamed BBV154, which has now been rechristened iNCOVACC became the world's first intranasal Covid-19 vaccine to be granted emergency use authorization (EUA) after the Indian drug regulator approved it for a two-dose primary immunization of those aged 18 years and above. COVID-19 intranasal vaccine (BBV154) has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials phase III In July 2022, Revive Therapeutics Ltd. is pleased to provide an update on the Company's U.S. Food & Drug Administration ("FDA") Phase III clinical trial (the "Study") (NCT04504734) to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19. The Company had unblinded the pre-dose selection data (the "Data") to potentially support the amended Study protocol with the new primary efficacy endpoints. The assigned unblinded statistician team is currently analyzing the Data, and the Company aims to submit the amended Study protocol to the FDA shortly thereafter. The proposed new primary efficacy endpoints may include the rate of sustained clinical resolution of symptoms of COVID-19, which addresses the shift in COVID-19 clinical outcomes observed over the course of the pandemic, and, therefore, to have more meaningful study endpoints for the FDA to consider for potential Emergency Use Authorization In April 2022, Direct Biologics, FDA approved the company to proceed with its Phase III clinical trial using its investigational EV drug, ExoFlo, to treat Acute Respiratory Distress Syndrome (ARDS) due to Covid-19. Direct Biologics is the first and only EV Company to receive FDA Phase III approval for an Investigational New Drug (IND) indication to date In April 2022, Direct Biologics announced that the US Food and Drug Administration (FDA) had awarded their EV drug product ExoFlo with a Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. In March 2022, Akston Biosciences Corp and Biolexis, a division of Stelis Biopharma Ltd., entered into a licensing, manufacturing, and commercialization agreement for Akston's AKS-452, a protein subunit COVID-19 vaccine. Biolexis gained the right to manufacture and commercialize AKS-452 (branded as AmbiVax-CTM) in India and over 130 countries in Asia, Latin America, and Africa, largely covering the low-and-middle-income countries (LMICs). Biolexis will also leverage the capabilities of Strides Group for launching this vaccine across regions where the group has a deep market presence, and established relationships Request a sample and discover the recent advances in COVID-19 treatment @ COVID-19 Competitive Landscape Report COVID-19 Overview Coronavirus disease (COVID-19) is an infectious disease caused by the most recently discovered coronavirus, SARS coronavirus 2. (SARS-CoV-2). COVID-19 causes a respiratory illness similar to the flu. The COVID-19 symptoms include cough, fever, and difficulty breathing. The majority of people infected with the COVID-19 virus will experience mild to moderate respiratory illness and will recover without the need for special care. People over the age of 65 and those with underlying medical conditions such as cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illnesses. When an infected person coughs or sneezes, the COVID-19 virus is primarily transmitted through saliva or nasal discharge droplets. Discover more about COVID-19 testing @ New Treatment for COVID-19 COVID-19 Pipeline Analysis: Drug Profile Sargramostim: Nobelpharma Nobelpharma's drug Sargramostim is a synthetic version of a natural substance produced in the body. It is used to boost the body's production of white blood cells. Sargramostim is given to patients with decreased ability to produce white blood cells. It is also used in some medical procedures (for example, bone marrow/stem cell transplants). It is a supportive medication but does not aid cancer treatment. The product is currently in Phase II/III development for the treatment of COVID-19. Sotrovimab: Vir Biotechnology Vir Biotechnology's Sotrovimab is a monoclonal antibody that neutralizes SARS-CoV-2. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make resistance development more difficult. Sotrovimab, which incorporates Xencor, Inc.'s XtendTM technology, has also been designed to achieve high concentrations in the lungs for optimal penetration into SARS-CoV-2-affected airway tissues and to have an extended half-life. Discover more about the list of FDA-approved drugs for COVID-19 @ Antiviral Drugs for COVID-19 Treatment A snapshot of the COVID-19 Pipeline Drugs mentioned in the report: Learn more about the emerging COVID-19 pipeline therapies @ COVID-19 Clinical Trials Scope of the COVID-19 Competitive Landscape Report Coverage: Global Key COVID-19 Companies: Westvac Biopharma, Xenothera, Windtree Therapeutics, Vir Biotechnology, ViiV Healthcare, Verastem, VBL Therapeutics, Vasomune Therapeutics, Inc., Valneva, Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories, UNION Therapeutics, Trustem, Toscana Life Sciences, Throne Biotechnologies, Thirty respiratory Limited, Theravance Biopharma, TC BioPharm, Syntax for Science, S.L, SyneuRx, Swedish Orphan Biovitrum, Swedish Herbal Institute AB, Stemedica Cell Technologies, Staidson (Beijing) Biopharmaceuticals Co., Ltd, Sound Pharmaceuticals, Sorrento Therapeutics, SolAeroMed, SK Bioscience, Sinovac Biotech Co., Ltd, Sinocelltech, Shenzhen Kangtai Biological Products Co., Ltd., Shaperon, Senhwa Biosciences, Inc., Selva Therapeutics, Archivel Farma, R-Pharm, Rohto Pharmaceutical, Revimmune, Resverlogix Corporation, Restorbio, Resolve Therapeutics, Renibus Therapeutics, ReiThera, Regeneron Pharmaceuticals, RedHill Biopharma, Red de Terapia Celular, Reata Pharmaceuticals, Inc., Qurient Co, Quercis Pharma, PureTech, Pulmotect, PTC Therapeutics, Pluristem Ltd., Pliant Therapeutics, Pharming Technologies B.V., Pharmenterprises, Pharmamel S.L., Pharma Holdings, Pharco Pharmaceuticals, Pfizer, Petrovax, Paion UK Ltd., Ashvattha Therapeutics, Inc. (Orpheris), OPKO Health, Oncotelic Inc., National Resilience, Inc. (Ology Bioservices), Olatec Therapeutics LLC, Novavax, Novartis Pharmaceuticals, Notitia Biotechnologies Company, Noorik Biopharmaceuticals, Nobelpharma, Moderna, Moderna, MetrioPharm, Merck Sharp & Dohme Corp., Merck KGaA, Medicago Inc., Mallinckrodt, Mabwell (Shanghai) Bioscience Co., Ltd., Lifefactors Zona Franca, Leading BioSciences, Kiniksa Pharmaceuticals, Ltd., 3M, 4D Pharma, AbbVie, Apotex, AgelessRx, AgenTus Therapeutics, AiCuris, AlloVir, Apeiron Biologics, Bausch Health Americas, BeiGene, Biotest, Bio-Thera Solutions, Cadila Healthcare Limited, Cellenkos, Cellularity Incorporated, Chiesi Farmaceutici S.p.A., Clene Nanomedicine, Codagenix, Debiopharm, Direct Biologics, Eiger BioPharmaceuticals, Emergent Biosolutions, Enlivex Therapeutics, Evergreen Therapeutics, Faron Pharmaceuticals, Frontier Biotechnologies, FSD Pharma, Genentech, Inc., Globavir Biosciences, Grand Medical, Grifols Therapeutics LLC, Inotrem, Ionis Pharmaceuticals, Jazz Pharmaceuticals, Kamada, Kiadis Pharma, Medicine Invention, MedRegen LLC, Miltenyi Biomedicine, Natureceuticals Sdn Bhd, NeoImmune Tech, Neutrolis, Ology Bioservices, Oncovir, OPKO Health, Organicell Regenerative Medicine, and others Key COVID-19 Pipeline Therapies: XAV-19, Sinapultide, VIR-7831, Maraviroc, Duvelisib, VB 201, AV-001, VLA2001, T3 solution for injection, UNIKINON, UNI911, Umbilical cord derived mesenchymal stem cells, MAD0004J08, Stem Cell Educator therapy, RESP301, TD-0903, TCB008, Bemiparin, Pentarlandir™ UPPTA, Emapalumab, Kan Jang capsules, hMSC, BDB-001, Ebselen, COVI-DROPS| Placebo, STI-5656, COVI-AMG, PSC-04, S-1226, GBP510, SARS-COV-2 inactivated vaccine, SCTA01, SARS-CoV-2 Vaccine (Vero Cells), Inactivated, NuSepin, Silmitasertib, SLV213, RUTI® vaccine, Olokizumab + RPH-104, Mesenchymal stem cell (ADR-001), CYT107, Apabetalone, RTB101, RSLV-132, RBT-9, GRAd-COV2, REGN-COV2 Antibody Cocktail, ABC 294640, Upamostat, Mesenchymal Stromal Cells, Bardoxolone methyl, Telacebec, IQC-950AN, LYT-100, PUL-042, PTC-299, PLX-PAD, PLN-74809, Conestat alfa, Treamid, Melatonin, LTX-109, Selenium, Ramipril, PF-06650833, Polyoxidonium, Remimazolam, OP-101, Rayaldee, OT-101, ADM03820, OLT 1177, NVXCoV 2373, DFV890, Crizanlizumab, MAS-825, NBT-NM108, Ambrisentan, Sargramostim, Gam-COVID-Vac, mRNA-1283, mRNA-1273, MP1032, Molnupiravir, M5049, Covifenz, INOmax, MW33, COVID-19 convalescent plasma, LB1148, Mavrilimumab, and others. Dive deep into rich insights for drugs for COVID-19 treatment; visit @ COVID-19 Vaccines Table of Contents For further information on the COVID-19 guidelines, reach out @ COVID-19 Treatment Guidelines Related Reports COVID-19 Pipeline COVID-19 Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key COVID-19 companies, including Chiesi Farmaceutici S.p.A., Clene Nanomedicine, Codagenix, Debiopharm, Direct Biologics, Eiger BioPharmaceuticals, Emergent Biosolutions, Enlivex Therapeutics, Evergreen Therapeutics, Faron Pharmaceuticals, among others. Common Cold Market Common Cold Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key common cold companies, including Sanotize Research and Development, Orbis Biosciences, Exscientia, EURRUS Biotech, among others. Common Cold Pipeline Common Cold Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key common cold companies, including Sanotize Research and Development, Orbis Biosciences, Exscientia, EURRUS Biotech, among others. Common Cold Epidemiology Common Cold Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted common cold epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Acute Respiratory Distress Syndrome Market Acute Respiratory Distress Syndrome Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key acute respiratory distress syndrome companies, including MediciNova, Edesa Biotech, Light Chain Biosciences, Boehringer Ingelheim, Genentech, among others. Chronic Obstructive Pulmonary Disease Market Chronic Obstructive Pulmonary Disease Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key chronic obstructive pulmonary disease companies, including United Therapeutics, Verona Pharma PLC, AstraZeneca, Chiesi Farmaceutici S.p.A., GlaxoSmithKline, among others. Other Trending Reports Goitre Market | Thymus Cancer Market | US Healthcare Outlook Report | Venous Stenosis Market | Negative Pressure Wound Therapy Systems Market | Global Kinase Inhibitor in Autoimmune Diseases Market | Metrorrhagia Market | Dysfunctional Uterine Bleeding Market | Hypereosinophilic Syndrome Market | Age-related Vision Dysfunction Market | Dental Lasers Market | CRISPR Therapies Pipeline Insight | Cell And Gene Therapy For Multiple Myeloma Market | Drug Hypersensitivity Market | Dysthymia Market | Persistent Depressive Disorder Market | Cancer Vaccines Market | Weight Loss/Weight Management (Obesity) Market | Food Allergy Market | Obsessive-Compulsive Disorder Market | Tumor Ablation Market | Physiotherapy Equipment Market | Chimeric Antigen Receptor (CAR) T-Cell Therapy Market | Anti-hypertension Market | Radiofrequency Ablation Devices Market | Global Messenger RNA (mRNA)-based Vaccines and Therapeutics Market | Gastro Intestinal Bleeding Market | Trastuzumab Biosimilars Insight | Varicose Veins Market | Germ Cell Tumor Market | Intracardiac Echocardiography Devices Market | India Healthcare Report | Crows Feet Market | Seborrhoeic Dermatitis Market | Injectable Drug Delivery Devices Market | Structural Heart Devices Market | Substance (Drug) Abuse Market | Insulin Glargine Biosimilar Insight Related Healthcare Blogs Increasing COPD Prevalence ARDS Market Outlook Emerging ARDS Therapies About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

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100 Deals associated with Zimlovisertib

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 2	US	Pfizer Inc.	06 Jan 2021
Hidradenitis Suppurativa	Phase 2	US	Pfizer Inc.	02 Dec 2019
Hidradenitis Suppurativa	Phase 2	AU	Pfizer Inc.	02 Dec 2019
Hidradenitis Suppurativa	Phase 2	CA	Pfizer Inc.	02 Dec 2019
Rheumatoid Arthritis	Phase 2	US	Pfizer Inc.	10 Nov 2016
Rheumatoid Arthritis	Phase 2	AU	Pfizer Inc.	10 Nov 2016
Rheumatoid Arthritis	Phase 2	BA	Pfizer Inc.	10 Nov 2016
Rheumatoid Arthritis	Phase 2	BG	Pfizer Inc.	10 Nov 2016
Rheumatoid Arthritis	Phase 2	HR	Pfizer Inc.	10 Nov 2016
Rheumatoid Arthritis	Phase 2	CZ	Pfizer Inc.	10 Nov 2016

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04092452 (Pubmed) Manual	Phase 2	Hidradenitis Suppurativa JAK1 \| TYK2	194	zimlovisertib 400 mg	dqaiwvhogx(ewemumcnbs) = pxivziqhaz ktunaekjpb (wcrrpmvbpn ) View more	Positive	27 Feb 2024
NCT05064332 (CTgov)	Phase 1	-	10	OC (Period 1: Oral Contraceptive)	dqpatybgrn(itteqijjxw) = eolmumsuid qpabqvapsh (jvznulrcit, pswhadmjrp - zdcnrsleyz) View more	-	02 Oct 2023
				PF-06650833 (Period 2: PF-06650833 + Oral Contraceptive)	dqpatybgrn(itteqijjxw) = dohsggysuf qpabqvapsh (jvznulrcit, qynvmoooeg - fohwavlfcd) View more
NCT04092452 (CTgov)	Phase 2	Hidradenitis Suppurativa	194	placebo+PF-06826647+PF-06700841+PF-06650833 (Placebo)	vvlngyvhlj(ituvhoqjax) = hfnsbuyawp vgxgoiiyeh (pbvsfexuwo, jiuyqxesqo - ufkvynhrkv) View more	-	15 Jun 2023
				PF-06650833 (PF-06650833 400mg QD)	vvlngyvhlj(ituvhoqjax) = jbfyfimral vgxgoiiyeh (pbvsfexuwo, udjllmmmvp - hfyaxrfqxi) View more
NCT04413617 (CTgov)	Phase 2	Rheumatoid Arthritis	460	Tofacitinib+PF-06650833 (PF-06650833 400mg MR + Tofacitinib 11mg MR)	uerdzropum(jrxevtjvjo) = ontfdizjpe wlytprnlqs (yhfomivtue, rfimpextvf - mqpnqhdlun) View more	-	07 Apr 2023
				MR+PF-06651600+PF-06650833 (PF-06650833 400mg MR + PF-06651600 100mg)	uerdzropum(jrxevtjvjo) = foroxskvnr wlytprnlqs (yhfomivtue, wboswwqvjj - iiyidlzbdi) View more
NCT02996500 (CTgov)	Phase 2	Rheumatoid Arthritis	269	Placebo	vhjlzqxomz(conoukuduz) = exetsjeivb ultbuqfylx (yajobcinfy, chlxacndpd - pmfsoqjudz) View more	-	27 Feb 2020
NCT02224651 (Pubmed) Manual	Phase 1	-	-	PF-06650833	amagwqgcse(vmriweefgr) = TEAEs were generally mild in severity, with headache, gastrointestinal disorders, and acne most commonly reported. fecjtkdnfv (miavyzagtv ) View more	Positive	05 Dec 2019
				Placebo

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