COVID-19 Pipeline Assessment, NDA Approvals, Clinical Trials, Emerging Drugs 2023 (Updated) | Renibus Therapeutics, Quercis Pharma, Pharmenterprises, and Others

DelveInsight's, "COVID-19 Pipeline Insight 2023," report provides comprehensive insights about 400+ companies and 400+ pipeline drugs in COVID-19 pipeline landscape. It covers the COVID-19 pipeline drug profiles, including COVID-19 clinical trials and nonclinical stage products. It also covers the COVID-19 therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
Recent Developmental Activities in the COVID-19 Treatment Landscape
• In January 2023, Frontier Biotechnologies Inc. initiated a trial titled, "A Phase II/III, Randomized,Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of FB2001 for Inhalation inPatients With Mild to Moderate COVID-19". This study is a double-blind, randomized, placebo-controlled study toevaluate the efficacy and safety of FB2001 for Inhalation in patients with mild to moderate Coronavirus Disease2019(COVID-19). A total of about 1336 subjects are planned to be enrolled. The subjects will be randomized in a 1:1ratio to FB2001 group or placebo group while both receiving standard of care treatment. The trial is currently activewith 1336 participants and is anticipated to be complete by September 2023
• In September 2022, Frontier Biotechnologies Inc. initiated a trial titled, "A Phase II/III, Double-Blind,Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of FB2001 in HospitalizedPatients With Moderate to Severe COVID-19". This study is a double-blind, randomized, placebo-controlled study toevaluate the efficacy and safety of FB2001 in hospitalized patients with moderate to severe Coronavirus Disease 2019(COVID-19). A total of about 1188 subjects are planned to be enrolled. The subjects will be randomized in a 1:1 ratio toFB2001 group or placebo group while both receiving standard of care treatment. This study is a double-blind,randomized, placebo-controlled study to evaluate the efficacy and safety of FB2001 in hospitalized patients withmoderate to severe Coronavirus Disease 2019 (COVID 19). A total of about 1188 subjects are planned to be enrolled.The subjects will be randomized in a 1:1 ratio to FB2001 group or placebo group while both receiving standard of caretreatment. The trial is currently active with 1188 participants and is anticipated to be complete by November 2023.
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COVID-19 Overview
Coronavirus disease (COVID-19) is an infectious disease caused by the most recently discovered corona virus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease causes respiratory illness (like the flu) with symptoms such as a cough, fever, and difficulty breathing.
Key Takeaways from the COVID-19 Pipeline Report
• Over 400+ COVID-19 companies are evaluating 400+ COVID-19 pipeline therapies in various stages of development, and their anticipated acceptance in the COVID-19 market would significantly increase market revenue.
• The leading COVID-19 companies include Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A., TC BioPharm, Syntax for Science, S.L, Shaperon, Renibus Therapeutics, Quercis Pharma, Pharmenterprises, Pharmamel S.L., Orpheris, OPKO Health, Oncotelic Inc., Notitia Biotechnologies Company, Jazz Pharmaceuticals, Ionis Pharmaceuticals, Inotrem, Grifols Therapeutics LLC, Grifols Therapeutics LLC, Grifols Therapeutics, Globavir Biosciences, Genentech, Inc., FSD Pharma, Faron Pharmaceuticals, Evergreen Therapeutics, Enlivex Therapeutics, Eiger BioPharmaceuticals, Direct Biologics, Debiopharm, Clene Nanomedicine, Chiesi Farmaceutici S.p.A., Cadila Healthcare Limited, Biotest, BeiGene, Apeiron Biologics, AgelessRx, AbbVie/Apotex, Telios Pharmaceuticals, Rapa Therapeutics, Organicell Regenerative Medicine, Miltenyi Biomedicine, MedRegen LLC, Kiadis Pharma, Kamada, Cellularity Incorporated, Bio-Thera Solutions, 3M, Sironax, Pfizer, Oncovir, Ology Bioservices, Neutrolis, NeoImmune Tech, Natureceuticals Sdn Bhd, Medicine Invention, Kiadis Pharma, Grand Medical, Frontier Biotechnologies, Emergent Biosolutions, Codagenix, Cellenkos, AlloVir, Bausch Health Americas, AiCuris, AgenTus Therapeutics, 4D Pharma, and others
• Promising COVID-19 Pipeline Therapies in various stage 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.
• The COVID-19 Companies and academics are working to assess challenges and seek opportunities that could influence COVID-19 R&D. The COVID-19 pipeline therapies under development are focused on novel approaches to treat/improve COVID-19.
For further information, refer to the detailed COVID-19 Drugs Launch, COVID-19 Developmental Activities, and COVID-19 News, click here for COVID-19 Ongoing Clinical Trial Analysis- https://www.delveinsight.com/sample-request/covid-19-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr
COVID-19 Emerging Drugs
• REGN-COV2: Regeneron Pharmaceuticals
REGN-COV2 Antibody Cocktail (Casirivimab and Imdevimab; REGN10933 + REGN10987) is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19. To develop REGN-COV2, Regeneron scientists evaluated thousands of fully-human antibodies produced by the company's VelocImmune® mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19. The two potent, virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population
• Bucillamine: Revive Therapeutics
Bucillamine, a cysteine derivative with two thiol groups, has been shown to be 16 times more potent as a thiol donor in vivo than NAC.2 The drug is non-toxic with high cellular permeability. The basis of the clinical study will analyze if Bucillamine has the potential, via increasing glutathione activity and other antioxidant and anti-inflammatory activity, to lessen the destructive consequences of SARS-CoV2 infection in the lungs and attenuate the clinical course of COVID-19.
• Mupadolimab (CPI-006): Corvus Pharmaceuticals
Mupadolimab (CPI-006) is an antibody that possesses dual properties: binding to CD73, which may reduce its suppression of the immune response via the adenosine pathway; and activating B cells, which may result in increased antibody production to antigens and the generation of memory B cells to extend protection.
• VERU 111: Veru Inc.
Sabizabulin is a cytoskeleton disruptor which by causing microtubule depolymerization has both anti-viral and anti-inflammatory activity and could be effective against the SARS-CoV-2 virus by disrupting its intracellular transport along the microtubules. Microtubule trafficking is critical for viruses to be transported, replicated, assembled, and released from the cell. In addition, microtubule depolymerization drugs that target the "colchicine binding site" of microtubules, like sabizabulin, also have strong anti-inflammatory effects, including the potential to treat the cytokine release syndrome (cytokine storm) and septic shock induced by the SARS-CoV-2 viral infection that is associated with high COVID-19 mortality rates.
• Sarconeos (BIO101): Biophytis
Sarconeos (BIO101) is an orally administered small molecule in development for the treatment of neuromuscular diseases. Based on results from cellular and animal studies, it is believed that Sarconeos (BIO101) stimulates biological resilience through activation of the MAS receptor and may have the potential to improve muscle function and preserve strength, mobility and respiratory capacity in various age-related and muscular wasting conditions.
• Leronlimab: CytoDyn
Leronlimab is a humanized monoclonal antibody targeted against the CCR5 receptor found on T lymphocytes of the human immune system. It is being investigated as a potential therapy in the treatment of COVID-19 infection.
• Tocilizumab: Hoffmann-La Roche
Actemra/RoActemra (Tocilizumab) is being developed by Hoffmann-La Roche in phase III stage of development for the treatment of Severe COVID-19 Pneumonia. Actemra/RoActemra is an anti-IL-6 receptor biologic approved to treat moderate-to-severe active rheumatoid arthritis (RA) in adults. The IL-6 protein triggers the body's immune and inflammatory response to fight infections. But, in the case of those patients where their immune system overreacts, inhibiting IL-6 could keep the body from attacking itself.
In Mar 2020, Roche received Chinese approval for the use of the drug to treat patients developing severe complications from Covid-19.
The new randomized, double-blind, placebo-controlled Phase III trial will be conducted in alliance with the US Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA). It will assess the safety and efficacy of Actemra in combination with standard of care compared to placebo.
COVID-19 Pipeline Therapeutics Assessment
There are approx. 400+ key companies which are developing the therapies for COVID-19. The companies which have their COVID-19 drug candidates in the most advanced stage, i.e. phase III include, Regeneron Pharmaceuticals.
Find out more about the COVID-19 Pipeline Segmentation, Therapeutics Assessment, and COVID-19 Emerging Drugs @ COVID-19 Treatment Landscape- https://www.delveinsight.com/sample-request/covid-19-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr
Scope of the COVID-19 Pipeline Report
• Coverage- Global
• COVID-19 Companies- Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A., TC BioPharm, Syntax for Science, S.L, Shaperon, Renibus Therapeutics, Quercis Pharma, Pharmenterprises, Pharmamel S.L., Orpheris, OPKO Health, Oncotelic Inc., Notitia Biotechnologies Company, Jazz Pharmaceuticals, Ionis Pharmaceuticals, Inotrem, Grifols Therapeutics LLC, Grifols Therapeutics LLC, Grifols Therapeutics, Globavir Biosciences, Genentech, Inc., FSD Pharma, Faron Pharmaceuticals, Evergreen Therapeutics, Enlivex Therapeutics, Eiger BioPharmaceuticals, Direct Biologics, Debiopharm, Clene Nanomedicine, Chiesi Farmaceutici S.p.A., Cadila Healthcare Limited, Biotest, BeiGene, Apeiron Biologics, AgelessRx, AbbVie/Apotex, Telios Pharmaceuticals, Rapa Therapeutics, Organicell Regenerative Medicine, Miltenyi Biomedicine, MedRegen LLC, Kiadis Pharma, Kamada, Cellularity Incorporated, Bio-Thera Solutions, 3M, Sironax, Pfizer, Oncovir, Ology Bioservices, Neutrolis, NeoImmune Tech, Natureceuticals Sdn Bhd, Medicine Invention, Kiadis Pharma, Grand Medical, Frontier Biotechnologies, Emergent Biosolutions, Codagenix, Cellenkos, AlloVir, Bausch Health Americas, AiCuris, AgenTus Therapeutics, 4D Pharma, and others
• 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.
• COVID-19 Pipeline Segmentation: Product Type, Molecule Type, Route of Administration
Dive deep into rich insights for drugs for COVID-19 Pipeline Companies and Therapies, click here @ COVID-19 Unmet Needs and Analyst Views- https://www.delveinsight.com/sample-request/covid-19-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr
Table of Content
1. Introduction
2. COVID-19 Executive Summary
3. COVID-19: Overview
4. COVID-19 Pipeline Therapeutics
5. COVID-19 Pipeline Therapeutic Assessment
6. Late Stage Products (Phase III)
7. REGN-COV2: Regeneron Pharmaceuticals
8. Drug profiles in the detailed report…..
9. Mid Stage Products (Phase II)
10. CNM-ZnAg: Clene Nanomedicine
11. Drug profiles in the detailed report…..
12. Early Stage Products (Phase I)
13. SIR1-365: Sironax
14. Drug profiles in the detailed report…..
15. Preclinical and Discovery Stage Products
16. SB019: Novan
17. Drug profiles in the detailed report…..
18. Inactive Products
19. COVID-19 Key Companies
20. COVID-19 Key Products
21. COVID-19- Unmet Needs
22. COVID-19- Market Drivers and Barriers
23. COVID-19- Future Perspectives and Conclusion
24. COVID-19 Analyst Views
25. COVID-19 Key Companies
26. Appendix
Got Queries? Find out the related information on COVID-19 Mergers and acquisitions, COVID-19 Licensing Activities @ COVID-19 Recent Trends, and Future Perspectives- https://www.delveinsight.com/sample-request/covid-19-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

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