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Trials |  |
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- ||| cipargamin (KAE609) / Novartis, INE963 / Novartis, ganaplacide/lumefantrine (KLU156) / Novartis
Enrollment change, Trial completion date: PLATINUM: Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Falciparum Malaria (clinicaltrials.gov) - May 22, 2024
P2, N=327, Recruiting, Sponsor: Novartis Pharmaceuticals
N=207 --> 327 | Trial completion date: Oct 2025 --> May 2026
- |||| cipargamin (KAE609) / Novartis, INE963 / Novartis, ganaplacide/lumefantrine (KLU156) / Novartis
Enrollment open, Combination therapy, Monotherapy: PLATINUM: Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Falciparum Malaria (clinicaltrials.gov) - Jan 17, 2024
P2, N=207, Recruiting, Sponsor: Novartis Pharmaceuticals
N=207 --> 327 | Trial completion date: Oct 2025 --> May 2026 Not yet recruiting --> Recruiting
- |||| INE963 / Novartis
Trial termination: Study of Safety, Tolerability, and Pharmacokinetics of INE963 in Healthy Participants (clinicaltrials.gov) - Sep 28, 2023
P1, N=64, Terminated, Sponsor: Novartis Pharmaceuticals
Not yet recruiting --> Recruiting Completed --> Terminated; Sponsor's decision.
- || Review, Journal: Recent developments in antimalarial drug discovery. (Pubmed Central) - Jun 2, 2023
Although these adjuvants have no antiplasmodial activity, they can help to alleviate the effects which result from plasmodium invasion such as cytoadherence. The list of new antimalarial drugs under development is long, including the out of ordinary new drugs MMV048, CDRI-97/78 and INE963 from South Africa, India and Novartis, respectively.
- ||| INE963 / Novartis
Trial completion: Study of Safety, Tolerability, and Pharmacokinetics of INE963 in Healthy Participants (clinicaltrials.gov) - Apr 27, 2023
P1, N=64, Completed, Sponsor: Novartis Pharmaceuticals
The list of new antimalarial drugs under development is long, including the out of ordinary new drugs MMV048, CDRI-97/78 and INE963 from South Africa, India and Novartis, respectively. Terminated --> Completed
- |||| cipargamin (KAE609) / Novartis, INE963 / Novartis, ganaplacide/lumefantrine (KLU156) / Novartis
New P2 trial, Combination therapy, Monotherapy: PLATINUM: Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Falciparum Malaria (clinicaltrials.gov) - Mar 2, 2023
P2, N=180, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
- |||| INE963 / Novartis
Trial completion date, Trial termination: Study of Safety, Tolerability, and Pharmacokinetics of INE963 in Healthy Participants (clinicaltrials.gov) - Feb 8, 2023
P1, N=64, Terminated, Sponsor: Novartis Pharmaceuticals
Terminated --> Completed Trial completion date: Mar 2023 --> Nov 2022 | Recruiting --> Terminated; Sponsor's decision.
- | INE963 / Novartis
Trial completion date: Study of Safety, Tolerability, and Pharmacokinetics of INE963 in Healthy Participants (clinicaltrials.gov) - Sep 29, 2022
P1, N=76, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Mar 2023 --> Nov 2022 | Recruiting --> Terminated; Sponsor's decision. Trial completion date: Nov 2022 --> Mar 2023
- || INE963 / Novartis
Enrollment change: Study of Safety, Tolerability, and Pharmacokinetics of INE963 in Healthy Participants (clinicaltrials.gov) - Jun 21, 2022
P1, N=76, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Nov 2022 --> Mar 2023 N=53 --> 76
- | INE963 / Novartis
Preclinical, Journal: Discovery and Preclinical Pharmacology of INE963, a Potent and Fast-Acting Blood-Stage Antimalarial with a High Barrier to Resistance and Potential for Single-Dose Cures in Uncomplicated Malaria. (Pubmed Central) - May 7, 2022
These properties suggest the significant potential for INE963 (1) to provide a curative therapy for uncomplicated malaria with short dosing regimens. For these reasons, INE963 (1) was progressed through GLP toxicology studies and is now undergoing Ph1 clinical trials.
- INE963 / Novartis
Discovery of clinical candidate INE963: A potent and fast-acting blood-stage antimalarial with a high barrier to resistance and potential for single-dose cure in uncomplicated malaria. (Room 1A (San Diego Convention Center)) - Jan 28, 2022 - Abstract #ACSSp2022ACS_Sp_4092;
Taken together, these properties craft a great potential for INE963 to provide a curative therapy for uncomplicated malaria with short dosing regimens. For these reasons, INE963 was progressed through GLP toxicology studies and is now undergoing Ph1 clinical trials.
- || INE963 / Novartis
Trial completion date, Trial primary completion date: Study of Safety, Tolerability, and Pharmacokinetics of INE963 in Healthy Participants (clinicaltrials.gov) - Nov 26, 2021
P1, N=53, Recruiting, Sponsor: Novartis Pharmaceuticals
For these reasons, INE963 was progressed through GLP toxicology studies and is now undergoing Ph1 clinical trials. Trial completion date: Nov 2021 --> Jun 2022 | Trial primary completion date: Nov 2021 --> Jun 2022
- ||| INE963 / Novartis
New P1 trial: Study of Safety, Tolerability, and Pharmacokinetics of INE963 in Healthy Participants (clinicaltrials.gov) - May 20, 2021
P1, N=53, Recruiting, Sponsor: Novartis Pharmaceuticals