Nicorandil

Unicycive Announces Acceptance of Four Abstracts for Presentation at the World Congress of Nephrology 2023

Retrieved on: 
Thursday, January 5, 2023

LOS ALTOS, Calif., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that four abstracts have been accepted for presentation at the upcoming International Society of Nephrology’s World Congress of Nephrology 2023 meeting taking place in Bangkok, Thailand from March 30 – April 2, 2023.

Key Points: 
  • LOS ALTOS, Calif., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that four abstracts have been accepted for presentation at the upcoming International Society of Nephrology’s World Congress of Nephrology 2023 meeting taking place in Bangkok, Thailand from March 30 – April 2, 2023.
  • “With our recently announced successful bioequivalence study of Renazorb compared to Fosrenol®, we are looking forward to filing a New Drug Application with the U.S. Food and Drug Administration in mid-2023.
  • These data provide further evidence of the benefits of Renazorb as a powerful phosphate binder and highlight its enhanced product profile, which is expected to improve medication compliance and, thereby, improve outcomes and quality-of-life for patients.”
    “The exposure of these favorable data before an audience of international nephrologists should further expand awareness of the advantages of Renazorb to treat hyperphosphatemia and should bolster our positioning in any potential partnership or licensing discussions,” added Dr. Gupta.
  • Fosrenol is a registered trademark of Shire International Licensing BV.

Unicycive Issued Notice of Acceptance to Initiate Phase 1 Study of UNI-494 Following Review of Clinical Trial Application by the Medicines and Healthcare Products Regulatory Agency in the United Kingdom

Retrieved on: 
Thursday, December 22, 2022

LOS ALTOS, Calif., Dec. 22, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, announced today that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (UK) has completed review of the Clinical Trial Application (CTA) and has issued a notice of acceptance for UNI-494 first-in-human Phase 1 study in healthy volunteers.

Key Points: 
  • LOS ALTOS, Calif., Dec. 22, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, announced today that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (UK) has completed review of the Clinical Trial Application (CTA) and has issued a notice of acceptance for UNI-494 first-in-human Phase 1 study in healthy volunteers.
  • “With this notice of acceptance from the MHRA, we look forward to proceeding to first-in-human clinical trials with our second drug, UNI-494,” stated Shalabh Gupta, MD, Chief Executive Officer of Unicycive.
  • “We are studying UNI-494 initially in the UK as its active metabolite, nicorandil, has been extensively studied throughout Europe, including in the UK.
  • We’ve selected a qualified UK-based Contract Research Organization (CRO) to conduct the Phase 1 study, which we expect will begin dosing patients in the first quarter of 2023.

Unicycive Reports Key Findings of UNI-494 Efficacy in Preclinical Animal Model of Geographic Atrophy

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Monday, November 21, 2022

LOS ALTOS, Calif., Nov. 21, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with unmet medical needs, today announced key findings of UNI-494 efficacy from a preclinical study in animal models of Geographic Atrophy (GA).

Key Points: 
  • LOS ALTOS, Calif., Nov. 21, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc.(Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with unmet medical needs, today announced key findings of UNI-494 efficacy from a preclinical study in animal models of Geographic Atrophy (GA).
  • The Company evaluated the effect of UNI-494 in preventing visual function loss in a rat model of GA.
  • The study evaluated four groups (n=8 per group): untreated, vehicle control, low dose of UNI-494, and high dose of UNI-494.
  • Further preclinical studies are planned to investigate these promising findings of the effect of UNI-494 in improving visual function.

Unicycive Announces Third Quarter Financial Results and Provides Business Update

Retrieved on: 
Monday, November 14, 2022

LOS ALTOS, Calif., Nov. 14, 2022 (GLOBE NEWSWIRE) --  Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the third quarter ended September 30, 2022, and provided a business update.

Key Points: 
  • The third quarter of 2022 and recent weeks have been particularly productive as we completed enrollment of our pivotal bioequivalence trial of RENAZORB, with topline results expected by year-end.
  • We remain on track to file a New Drug Application (NDA) in 2023, saidShalabh Gupta, M.D., Chief Executive Officer of Unicycive.
  • Dr. Gupta added, We were delighted to share favorable results from both our product candidates with the nephrology community at this years Kidney Week.
  • General and administrative expenses for the quarter ended September 30, 2022 were $1.7 million, compared with $0.9 million for the same quarter in 2021.

Unicycive Reports Key Findings of UNI-494 Efficacy in Preclinical Animal Model of Acute Kidney Injury (AKI)

Retrieved on: 
Wednesday, September 7, 2022

LOS ALTOS, Calif., Sept. 07, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced key findings of UNI-494 efficacy from a preclinical study in rodent model of Acute Kidney Injury.

Key Points: 
  • LOS ALTOS, Calif., Sept. 07, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc.(Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced key findings of UNI-494 efficacy from a preclinical study in rodent model of Acute Kidney Injury.
  • The Company evaluated the effect of UNI-494 on ischemia-reperfusion induced acute kidney injury (IR-AKI) in rats.
  • We are excited to report this key finding from the IR-AKI model showing treatment with UNI-494 significantly reduced this key biomarker of kidney injury that is a well-accepted biomarker of proximal renal tubule damage.
  • UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment of acute kidney injury.For more information, please visit www.unicycive.com .

Unicycive Announces Multiple Abstracts Selected for Presentation at American Society of Nephrology’s Kidney Week 2022

Retrieved on: 
Wednesday, August 24, 2022

All abstracts for ASNs Kidney Week 2022 will be available via the ASN website ( www.asn-online.org/education/kidneyweek ) by October 14, 2022.

Key Points: 
  • All abstracts for ASNs Kidney Week 2022 will be available via the ASN website ( www.asn-online.org/education/kidneyweek ) by October 14, 2022.
  • Renazorb has been shown to offer unique phosphate binding characteristics, which have the potential to treat hyperphosphatemia in chronic kidney disease patients.
  • Unicycive is preparing a clinical bioequivalence study performed in healthy volunteers in order to submit a 505(b)(2) new drug application to the U.S. Food and Drug Administration.
  • UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment of acute kidney injury.For more information, please visit www.unicycive.com .

China Nicorandil Market Research Report 2022: Sales 2017-2021, Major Manufacturers 2017-2021, Sales Prices 2021-2022, Future Prospects 2022-2031 - ResearchAndMarkets.com

Retrieved on: 
Monday, August 8, 2022

The "Research Report on China's Nicorandil Market, 2022-2031" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Research Report on China's Nicorandil Market, 2022-2031" report has been added to ResearchAndMarkets.com's offering.
  • The analyst survey data show that from 2017 to 2021, the sales value of nicorandil in the Chinese market kept increasing year by year.
  • The dosage forms of nicorandil sold in China include tablets and injection, with the latter already occupying the major market share in terms of sales value.
  • The rising number of patients with coronary heart disease in China has contributed to the growth of the related drug market.

China Nicorandil Market Research Report 2021: Sales 2016-2020, Major Manufacturers, Prices 2020-2021, Prospects 2021-2025 - ResearchAndMarkets.com

Retrieved on: 
Thursday, March 10, 2022

The "Research Report on China's Nicorandil Market, 2021-2025" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Research Report on China's Nicorandil Market, 2021-2025" report has been added to ResearchAndMarkets.com's offering.
  • The rising number of patients with coronary heart disease in China has contributed to the growth of the market.
  • The publisher's survey data show that from 2016 to 2020, the sales value of nicorandil in the Chinese market kept increasing year by year.
  • The dosage forms of nicorandil sold in China include tablets and injection, with the latter already occupying the major market share in terms of sales value.