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Trials |  |
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- | RP7214 / Rhizen
Enrollment change, Trial withdrawal, Combination therapy: Study to Evaluate the Safety, Pharmacokinetics and Clinical Activity of RP7214 in Combination With Azacitidine in Patients With Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Acute Myeloid Leukemia (clinicaltrials.gov) - Oct 31, 2022
P1/2, N=0, Withdrawn, Sponsor: Rhizen Pharmaceuticals SA
N=36 --> 0 | Not yet recruiting --> Withdrawn
- || RP7214 / Rhizen
Clinical, PK/PD data, Journal: A First in man study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of RP7214, a Dihydroorotate Dehydrogenase (DHODH) inhibitor in Healthy Subjects. (Pubmed Central) - Oct 12, 2022
P1
Inhibition of DHODH, as evidenced by increased DHO levels was observed, confirming target engagement. The high systemic exposure with a favourable safety profile shows potential for the development of RP7214 in SARS-CoV-2 and acute myeloid leukemia (NCT04680429).
- | RP7214 / Rhizen
Trial initiation date, Combination therapy: Study to Evaluate the Safety, Pharmacokinetics and Clinical Activity of RP7214 in Combination With Azacitidine in Patients With Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Acute Myeloid Leukemia (clinicaltrials.gov) - Aug 18, 2022
P1/2, N=36, Not yet recruiting, Sponsor: Rhizen Pharmaceuticals SA
The high systemic exposure with a favourable safety profile shows potential for the development of RP7214 in SARS-CoV-2 and acute myeloid leukemia (NCT04680429). Initiation date: Apr 2022 --> Jan 2023
- ||| RP7214 / Rhizen
Trial completion: Study to Evaluate the Efficacy and Safety of Oral RP7214, a DHODH Inhibitor, in Patients With Symptomatic Mild COVID-19 Infection. (clinicaltrials.gov) - Apr 21, 2022
P2, N=163, Completed, Sponsor: Rhizen Pharmaceuticals SA
Initiation date: Apr 2022 --> Jan 2023 Recruiting --> Completed
- RP7214 / Rhizen
Activity of RP7214, a novel, selective, and potent small molecule inhibitor of DHODH, in AML (E-Poster Website) - Mar 9, 2022 - Abstract #AACR2022AACR_6951;
Results demonstrate the utility of RP7214 as a single agent and in combination with standard of care drugs in inducing apoptosis and promoting differentiation to fully mature cells in AML. A Phase 2a trial in AML patients is planned.
- || RP7214 / Rhizen
New P1/2 trial, Combination therapy: Study to Evaluate the Safety, Pharmacokinetics and Clinical Activity of RP7214 in Combination With Azacitidine in Patients With Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Acute Myeloid Leukemia (clinicaltrials.gov) - Feb 17, 2022
P1/2, N=36, Not yet recruiting, Sponsor: Rhizen Pharmaceuticals SA
- |||| RP7214 / Rhizen
Enrollment open: Study to Evaluate the Efficacy and Safety of Oral RP7214, a DHODH Inhibitor, in Patients With Symptomatic Mild COVID-19 Infection. (clinicaltrials.gov) - Sep 21, 2021
P2, N=204, Recruiting, Sponsor: Rhizen Pharmaceuticals SA
A Phase 2a trial in AML patients is planned. Not yet recruiting --> Recruiting
- || RP7214 / Rhizen
Trial completion: A Single and Multiple Ascending and Food Effect Study of RP7214, a DHODH Inhibitor in Healthy Adult Subjects (clinicaltrials.gov) - Aug 18, 2021
P1, N=42, Completed, Sponsor: Rhizen Pharmaceuticals SA
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- ||||| RP7214 / Rhizen
New P2 trial: Study to Evaluate the Efficacy and Safety of Oral RP7214, a DHODH Inhibitor, in Patients With Symptomatic Mild COVID-19 Infection. (clinicaltrials.gov) - Aug 16, 2021
P2, N=204, Not yet recruiting, Sponsor: Rhizen Pharmaceuticals SA
- || RP7214 / Rhizen
Enrollment closed: A Single and Multiple Ascending and Food Effect Study of RP7214, a DHODH Inhibitor in Healthy Adult Subjects (clinicaltrials.gov) - Jul 20, 2021
P1, N=42, Active, not recruiting, Sponsor: Rhizen Pharmaceuticals SA
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || RP7214 / Rhizen
Enrollment change, Trial primary completion date: A Single and Multiple Ascending and Food Effect Study of RP7214, a DHODH Inhibitor in Healthy Adult Subjects (clinicaltrials.gov) - Apr 22, 2021
P1, N=42, Recruiting, Sponsor: Rhizen Pharmaceuticals SA
Recruiting --> Active, not recruiting N=18 --> 42 | Trial primary completion date: Mar 2021 --> Jun 2021
- || RP7214 / Rhizen
Enrollment open: A Single and Multiple Ascending and Food Effect Study of RP7214, a DHODH Inhibitor in Healthy Adult Subjects (clinicaltrials.gov) - Dec 27, 2020
P1, N=18, Recruiting, Sponsor: Rhizen Pharmaceuticals SA
N=18 --> 42 | Trial primary completion date: Mar 2021 --> Jun 2021 Not yet recruiting --> Recruiting
- || RP7214 / Rhizen
New P1 trial: A Single and Multiple Ascending and Food Effect Study of RP7214, a DHODH Inhibitor in Healthy Adult Subjects (clinicaltrials.gov) - Dec 22, 2020
P1, N=18, Not yet recruiting, Sponsor: Rhizen Pharmaceuticals SA