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- ||| rezafungin IV (CD101 IV) / Cidara Therap, Mundipharma
8- مراجعة سريعة لأهم أربعة مضادات جديدة للفطريات : oteseconazole, rezafungin, ibrexafugigrep, encholeated AMB (Twitter) - Oct 4, 2021
- | rezafungin IV (CD101 IV) / Cidara Therap, Mundipharma
Journal: How urgent is the need for new antifungals? (Pubmed Central) - Oct 2, 2021
They also go on to describe the new antifungal agents that are in the clinical stage of development and how they might be best utilized in patient care in the future.Expert opinion: The antifungal drug development pipeline has responded to a growing need for new agents to effectively treat fungal disease without concomitant toxicity or issues with drug tolerance. Olorofim (F901318), ibrexafungerp (SCY-078), fosmanogepix (APX001), rezafungin (CD101), oteseconazole (VT-1161), encochleated amphotericin B (MAT2203), nikkomycin Z (NikZ) and ATI-2307 are all in the clinical stage of development and offer great promise in offering clinicians better agents to treat these difficult infections.
- ||| rezafungin IV (CD101 IV) / Cidara Therap, Mundipharma
Clinical, PK/PD data: .@CidaraThera #IDWeek2021 poster is available to view online: "Effect of Hepatic Impairment on the Safety and Pharmacokinetics of Rezafungin." https://t.co/pnxgd5trXa $CDTX (Twitter) - Sep 30, 2021
- | rezafungin IV (CD101 IV) / Cidara Therap, Mundipharma
Preclinical, Journal: The Long-Acting Echinocandin, Rezafungin, Prevents Pneumocystis Pneumonia and Eliminates Pneumocystis from the Lungs in Prophylaxis and Murine Treatment Models. (Pubmed Central) - Sep 29, 2021
These findings support the obligate role of sexual reproduction for survival and growth of Pneumocystis spp. and warrant further investigation for treatment of P. jirovecii pneumonia in humans.
- || rezafungin IV (CD101 IV) / Cidara Therap, Mundipharma
By comparison rezafungin got an additional 7 years of patent exclusivity on top of 5 years for QIDP. Ibrexa did too: https://t.co/0OVYzV6mxJ. 2/ (Twitter) - Aug 20, 2021
- |||| Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
Enrollment closed: ReSTORE: Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis (clinicaltrials.gov) - Aug 18, 2021
P3, N=199, Active, not recruiting, Sponsor: Cidara Therapeutics Inc.
and warrant further investigation for treatment of P. jirovecii pneumonia in humans. Recruiting --> Active, not recruiting
- || rezafungin IV (CD101 IV) / Cidara Therap, Mundipharma
Clinical, Journal: Lack of Effect of Rezafungin on QT/QTc Interval in Healthy Subjects. (Pubmed Central) - Aug 14, 2021
Electrocardiogram results showed no clinically significant effects of concern. These findings support the continued development of rezafungin.
- |||| Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
Trial completion date, Trial primary completion date: ReSTORE: Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis (clinicaltrials.gov) - Oct 5, 2020
P3, N=218, Recruiting, Sponsor: Cidara Therapeutics Inc.
These findings support the continued development of rezafungin. Trial completion date: Sep 2020 --> Aug 2021 | Trial primary completion date: Sep 2020 --> Aug 2021
- rezafungin IV (CD101 IV) / Cidara Therap, Mundipharma
[VIRTUAL] Phase 2 STRIVE Clinical Trial of Rezafungin for Treatment of Candidemia and/or Invasive Candidiasis Demonstrates Consistent Trough Concentrations Across Diverse Patient Populations () - Aug 14, 2020 - Abstract #IDWeek2020IDWEEK_1845;
P2
No meaningful differences in rezafungin Cmin values were observed in patients grouped by sex, race, or geographic region, or across a wide range of patient factors, including age and body weight and size. These findings indicate that a single rezafungin dose regimen can be expected to provide consistent PK across diverse patient populations.
- | Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Safety and Pharmacokinetics of Rezafungin (clinicaltrials.gov) - May 22, 2020
P1, N=14, Terminated, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
These findings indicate that a single rezafungin dose regimen can be expected to provide consistent PK across diverse patient populations. N=86 --> 14 | Trial completion date: Jan 2021 --> May 2020 | Recruiting --> Terminated | Trial primary completion date: Jan 2021 --> May 2020; Stopped due to the formation of injection site skin nodules.
- |||||| Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
Enrollment open: ReSPECT: Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (clinicaltrials.gov) - May 13, 2020
P3, N=462, Recruiting, Sponsor: Cidara Therapeutics Inc.
N=86 --> 14 | Trial completion date: Jan 2021 --> May 2020 | Recruiting --> Terminated | Trial primary completion date: Jan 2021 --> May 2020; Stopped due to the formation of injection site skin nodules. Not yet recruiting --> Recruiting
- |||||||||| Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
New P3 trial: ReSPECT: Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (clinicaltrials.gov) - Apr 29, 2020
P3, N=462, Not yet recruiting, Sponsor: Cidara Therapeutics Inc.
- | Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
Enrollment open: Safety and Pharmacokinetics of Rezafungin (clinicaltrials.gov) - Dec 1, 2019
P1, N=86, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
New P1 trial: Safety and Pharmacokinetics of Rezafungin (clinicaltrials.gov) - Oct 6, 2019
P1, N=82, Not yet recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
- | rezafungin IV (CD101 IV) / Cidara
PK/PD data, Journal: Overcoming the Resistance Hurdle: PK-PD Target Attainment Analyses of Rezafungin (CD101) forand. (Pubmed Central) - Aug 21, 2019
...Using a previously developed rezafungin population PK model, Monte Carlo simulations were conducted utilizing the following three intravenous rezafungin regimens: (i) a single 400 mg dose, (ii) 400 mg for week 1 followed by 200 mg weekly for 5 weeks, and (iii) 400 mg weekly for 6 weeks...Moreover, high (>90%) probabilities of PK-PD target attainment were achieved through Week 6 following administration of the weekly dosing regimens at or above the MICvalues forandbased on contemporarysurveillance data. These analyses support the use of single and once-weekly rezafungin dosing regimens for the treatment of patients with candidemia and/or candidiasis due toor
- | Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
Trial completion: STRIVE: CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension (clinicaltrials.gov) - Aug 1, 2019
P2, N=208, Completed, Sponsor: Cidara Therapeutics Inc.
These analyses support the use of single and once-weekly rezafungin dosing regimens for the treatment of patients with candidemia and/or candidiasis due toor Active, not recruiting --> Completed
- ||| Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
Enrollment closed: STRIVE: CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension (clinicaltrials.gov) - May 6, 2019
P2, N=208, Active, not recruiting, Sponsor: Cidara Therapeutics Inc.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- rezafungin IV (CD101 IV) / Cidara Therap, Mundipharma
Phase II STRIVE clinical trial of rezafungin for the treatment of candidaemia and/or invasive candidiasis: results stratified by baseline renal function () - Apr 5, 2019 - Abstract #ECCMID2019ECCMID_477;
P2
A lack of AUC trend by CrCl suggests renal elimination is not an important route of rezafungin clearance. Additional clinical evaluations are planned to further evaluate rezafungin in special populations.
- || Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
Trial completion date, Trial primary completion date: STRIVE: CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension (clinicaltrials.gov) - Jan 23, 2019
P2, N=227, Recruiting, Sponsor: Cidara Therapeutics Inc.
Additional clinical evaluations are planned to further evaluate rezafungin in special populations. Trial completion date: Dec 2018 --> Jul 2019 | Trial primary completion date: Oct 2018 --> Jun 2019
- | Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
Enrollment open: ReSTORE: Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis (clinicaltrials.gov) - Oct 1, 2018
P3, N=218, Recruiting, Sponsor: Cidara Therapeutics Inc.
Trial completion date: Dec 2018 --> Jul 2019 | Trial primary completion date: Oct 2018 --> Jun 2019 Not yet recruiting --> Recruiting
- | Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
New P3 trial: ReSTORE: Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis (clinicaltrials.gov) - Sep 12, 2018
P3, N=218, Not yet recruiting, Sponsor: Cidara Therapeutics Inc.
- ||| Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
Enrollment change, Trial completion date, Trial primary completion date: STRIVE: CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension (clinicaltrials.gov) - Jun 4, 2018
P2, N=227, Recruiting, Sponsor: Cidara Therapeutics Inc.
Not yet recruiting --> Recruiting N=114 --> 227 | Trial completion date: Nov 2017 --> Dec 2018 | Trial primary completion date: Oct 2017 --> Oct 2018
- Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
Trial completion date, Trial initiation date: Non-Interventional Extension to Investigate Recurrence of Vulvovaginal Candidiasis and Candida Colonization (clinicaltrials.gov) - Mar 3, 2018
P=N/A, N=32, Completed, Sponsor: Cidara Therapeutics Inc.
N=114 --> 227 | Trial completion date: Nov 2017 --> Dec 2018 | Trial primary completion date: Oct 2017 --> Oct 2018 Trial completion date: Mar 2017 --> Mar 2017 | Initiation date: Aug 2016 --> Aug 2016
- || Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
Trial primary completion date: STRIVE: CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension (clinicaltrials.gov) - Jul 13, 2017
P2, N=114, Recruiting, Sponsor: Cidara Therapeutics Inc.
Trial completion date: Mar 2017 --> Mar 2017 | Initiation date: Aug 2016 --> Aug 2016 Trial primary completion date: Jun 2017 --> Oct 2017
- | Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
Trial completion: Non-Interventional Extension to Investigate Recurrence of Vulvovaginal Candidiasis and Candida Colonization (clinicaltrials.gov) - Jun 4, 2017
P=N/A, N=32, Completed, Sponsor: Cidara Therapeutics Inc.
Trial primary completion date: Jun 2017 --> Oct 2017 Active, not recruiting --> Completed
- Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
Enrollment closed, Enrollment change: Non-Interventional Extension to Investigate Recurrence of Vulvovaginal Candidiasis and Candida Colonization (clinicaltrials.gov) - Mar 27, 2017
P=N/A, N=32, Active, not recruiting, Sponsor: Cidara Therapeutics Inc.
Active, not recruiting --> Completed Enrolling by invitation --> Active, not recruiting | N=125 --> 32
- ||| Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
New trial: Non-Interventional Extension to Investigate Recurrence of Vulvovaginal Candidiasis and Candida Colonization (clinicaltrials.gov) - Sep 2, 2016
P=N/A, N=125, Enrolling by invitation, Sponsor: Cidara Therapeutics Inc.
- ||| Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
Enrollment change: STRIVE: CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension (clinicaltrials.gov) - Jun 11, 2016
P2, N=114, Recruiting, Sponsor: Cidara Therapeutics Inc.
Enrolling by invitation --> Active, not recruiting | N=125 --> 32 N=90 --> 114
- |||| Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
Enrollment open: STRIVE: CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension (clinicaltrials.gov) - May 13, 2016
P2, N=90, Recruiting, Sponsor: Cidara Therapeutics Inc.
N=90 --> 114 Not yet recruiting --> Recruiting
- ||||| Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
New P2 trial: STRIVE: CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension (clinicaltrials.gov) - Apr 12, 2016
P2, N=90, Not yet recruiting, Sponsor: Cidara Therapeutics Inc.
- | Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
Trial completion: An Ascending Multiple Dose Study of CD101 IV in Healthy Subjects (clinicaltrials.gov) - Jan 11, 2016
P1, N=24, Completed, Sponsor: Cidara Therapeutics Inc.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
Enrollment closed: An Ascending Multiple Dose Study of CD101 IV in Healthy Subjects (clinicaltrials.gov) - Dec 3, 2015
P1, N=24, Active, not recruiting, Sponsor: Cidara Therapeutics Inc.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
Trial completion: A Single Ascending Dose Study of CD101 IV in Healthy Subjects (clinicaltrials.gov) - Oct 8, 2015
P1, N=32, Completed, Sponsor: Cidara Therapeutics Inc.
Recruiting --> Active, not recruiting Recruiting --> Completed
- Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
New P1 trial: An Ascending Multiple Dose Study of CD101 IV in Healthy Subjects (clinicaltrials.gov) - Sep 16, 2015
P1, N=24, Recruiting, Sponsor: Cidara Therapeutics Inc.
- Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
New P1 trial: A Single Ascending Dose Study of CD101 IV in Healthy Subjects (clinicaltrials.gov) - Aug 6, 2015
P1, N=32, Recruiting, Sponsor: Cidara Therapeutics Inc.