ATP2A1 inhibitors(Sarcoplasmic/endoplasmic reticulum calcium ATPase 1 inhibitors), DHPS inhibitors(Dihydropteroate synthase inhibitors), SERCA2 inhibitors(Sarcoplasmic/endoplasmic reticulum calcium ATPase 2 inhibitors)

Therapeutic Areas

Infectious Diseases

Active Indication-

Inactive Indication

MalariaMalaria, Falciparum

Originator Organization-

Active Organization-

Inactive Organization

GSK Plc

The University of Liverpool

MMV Medicines for Malaria Venture

License Organization-

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

Structure/Sequence

Molecular FormulaC12H12N2O2S

InChIKeyMQJKPEGWNLWLTK-UHFFFAOYSA-N

CAS Registry80-08-0

View All Structures (2)

Clinical Trials associated with Artesunate/Chlorproguanil/Dapsone

EUCTR2010-019983-35-BE

/ Not yet recruitingPhase 2IIT

Phase I-II study of low dose CdA combined with valproic acid (VPA) in previously treated B-cell chronic lymphocytic leukemia (CLL) patients. - VPA-CdA in CLL

Start Date24 Nov 2010

Sponsor / Collaborator

Cliniques Universitaires Saint-Luc

NCT00344006

/ CompletedPhase 3

A Multi-centre, Randomised, Double-blind, Double Dummy Study Comparing the Efficacy and Safety of Chlorproguanil-dapsone-artesunate Versus Artemether-lumefantrine in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Children and Adolescents in Africa.

Chlorproguanil-dapsone has been approved for the treatment of uncomplicated Plasmodium falciparum malaria in a number of countries across sub-Sahara Africa, and by the UK's Medicines and Healthcare products Regulatory Agency.
CDA is a combination of chlorproguanil, dapsone and artesunate, being developed in a public-private partnership with the Medicines for Malaria Venture (MMV), World Health Organisation (WHO-TDR) and academic partners from the London School of Hygiene and Tropical Medicine, University of Liverpool and the Liverpool School of Tropical Medicine as a treatment for acute uncomplicated P. falciparum malaria.
The combination of chlorproguanil-dapsone-artesunate (CDA) is being developed to supersede chlorproguanil-dapsone for the same indication, but the addition of an artemisinin derivative, artesunate, should provide additional population benefits over chlorproguanil-dapsone alone. The artemisinins have been demonstrated to rapidly reduce parasite load and have activity against the sexual stages of the P.falciparum lifecycle. The addition of a second agent to the chlorproguanil-dapsone combination should also protect against the selection of resistant strains of P.falciparum.
Artemether-lumefantrine is the only available fixed-dose Artemisinin-based Combination Therapy actually available and is considered as the gold standard for the treatment of P. falciparum malaria. This study will therefore aim to demonstrate the non-inferiority of the combination of CDA to artemether-lumefantrine in terms of efficacy at 28-days. The key secondary objectives will compare the Parasite Clearance Times (PCT) and the Fever Clearance Times (FCT) between CDA and artemether-lumefantrine.

Start Date01 Jun 2006

Sponsor / Collaborator

GSK Plc

NCT00371735

/ CompletedPhase 3

A Multi-centre, Randomised, Double-blind Study to Compare the Efficacy and Safety of Chlorproguanil-dapsone-artesunate Versus Chlorproguanil-dapsone in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Children, Adolescents and Adults in Africa.

CDA is a combination of chlorproguanil, dapsone and artesunate, being developed in a public-private partnership with the Medicines for Malaria Venture (MMV), World Health Organisation (WHO-TDR) and academic partners from the London School of Hygiene and Tropical Medicine, University of Liverpool and the Liverpool School of Tropical Medicine as a treatment for acute uncomplicated P. falciparum malaria.
The combination of chlorproguanil HCl (CPG) and dapsone (DDS) as chlorproguanil-dapsone has already been shown to be efficacious against P.falciparum in adults and children in Sub-Sahara Africa. The addition of artesunate to LAPDAP has been demonstrated to increase the parasite kill rate as demonstrated in the phase II study, and reduce the chance of any parasites escaping treatment over the 3-day course. The addition of artesunate is also anticipated to have the population benefit of protection against the development of resistant strains of P.falciparum, although it will not be possible to demonstrate this in a clinical trial. One further population benefit of the artemisinin drugs are their ability to suppress the sexual forms of the parasite (gametocytes), which should reduce infectivity after antimalarial treatment and potentially lower transmission rates with widespread use, including the spread of any parasites resistant to the partner drug.
The aims of this phase III study are to compare the efficacy of a fixed ratio combination tablet of CDA to chlorproguanil-dapsone, and collect supporting safety data. This will be a multi-centre, double-blind, double-dummy, randomised trial, in children, adolescents and adults, with chlorproguanil-dapsone as a comparator.

Start Date01 Apr 2006

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with Artesunate/Chlorproguanil/Dapsone

100 Translational Medicine associated with Artesunate/Chlorproguanil/Dapsone

100 Patents (Medical) associated with Artesunate/Chlorproguanil/Dapsone

596

Literatures (Medical) associated with Artesunate/Chlorproguanil/Dapsone

01 May 2025·Spine Journal

Effect of industry funding on outcome reporting in cervical disc arthroplasty: a systematic review and meta-analysis of randomized controlled trials

Review

Author: Cheng, Boyle C ; Breyer, Garrett M ; Jeyamohan, Hareindra R ; Altman, Daniel T ; Zavras, Athan G ; Acosta, Jonathan R ; Holmberg, Kyle J ; Sauber, Ryan D

BACKGROUND CONTEXT:

Cervical Disc Arthroplasty (CDA) has been shown to be an effective and safe alternative to Anterior Cervical Discectomy and Fusion (ACDF), with randomized controlled trials (RCTs) reporting noninferior or even favorable outcomes to ACDF. However, the current literature of large RCTs reporting long-term outcomes of CDA primarily comprises of the industry sponsored Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trials. As a result, CDA has yet to be universally accepted by surgeons due to concerns of bias in the current literature.

PURPOSE:

To compare the outcomes of single-level CDA and ACDF by conducting a meta-analysis of RCTs, with a subgroup comparison of IDE and non-IDE trial results.

STUDY DESIGN:

Systematic review and meta-analysis.

PATIENT SAMPLE:

Nineteen studies (9 IDE, 10 non-IDE) reporting the outcomes of 18 RCTs were included with a total of 3054 patients (1691 CDA and 1363 ACDF). Among CDA patients, 1229 (72.7%) were enrolled in an FDA IDE trial, while 462 (27.3%) were involved in RCTs that were not funded by industry. Minimum follow-up among the RCTs included ranged from 2 to 10 years.

OUTCOME MEASURES:

Outcomes of interest included index and adjacent segment reoperation rates, postoperative disability as reported by the Neck Disability Index (NDI), and the Visual Analog Scale (VAS) for Neck and Arm pain.

METHODS:

A random effects meta-analysis was performed comparing CDA and ACDF by pooling the outcomes of all RCTs for each outcome of interest. A subgroup analysis was then performed comparing the pooled outcomes of the FDA IDE trials and non-IDE RCTs. Standardized mean differences (SMD) and log relative risk (RR) were used to analyze continuous and categorical variables with corresponding 95% confidence intervals (CI).

RESULTS:

Among all RCTs, there was a significantly lower risk for all secondary surgical interventions with CDA relative to ACDF (RR: 0.91, 95% CI: 0.55-1.28; p<.0001) in addition to lower risk for adjacent segment surgery (RR: 1.06, 95% CI: 0.66-1.45; p<.0001), and index segment reoperation (RR: 0.48, 95% CI: 0.005-0.96; p=.048). No significant differences in NDI, VAS Neck, or VAS Arm were found in the analyses comparing ACDF and CDA (p>.05). When comparing between the IDE and non-IDE trial subgroups, there were no significant differences noted in any assessed outcome (p>.05).

CONCLUSION:

CDA appears to be equivalent to ACDF in reducing postoperative pain and disability, while also potentially decreasing the risk for subsequent surgical intervention, as demonstrated by the FDA IDE trials and non-IDE RCTs without industry ties. While a large number of high-quality trials for CDA do pose a risk for bias due to industry sponsorship, the current literature of high-quality RCTs without industry affiliations corroborates similar findings.

01 May 2025·Spine Journal

Is cervical disc arthroplasty an effective treatment option for patients with cervical spondylotic myelopathy? A matched cohort analysis compared to anterior cervical discectomy and fusion

Article

Author: Emami, Arash ; Uppal, Harjot ; Sinha, Kumar ; Coban, Daniel ; Changoor, Stuart ; Sahai, Nikhil ; Patel, Neil ; Abdelmalek, George ; Hwang, Ki

BACKGROUND CONTEXT:

Cervical spondylotic myelopathy (CSM) is a progressive condition characterized by spinal cord compression secondary to disc degeneration. While anterior cervical discectomy and fusion (ACDF) has long been considered the standard surgical treatment for CSM, loss of motion segments after this procedure may lead to sequelae, including adjacent segment disease (ASD), further propagating loss of function and the potential requirement for revision procedures. More recently, cervical disc arthroplasty (CDA) has been introduced as a motion-preserving alternative to ACDF in CSM.

PURPOSE:

This study compares ACDF to CDA in patients with preoperative CSM.

STUDY DESIGN/SETTING:

A matched cohort retrospective study.

PATIENT SAMPLE:

About 110 patients were included in the final analysis; 55 underwent ACDF, and 55 underwent CDA.

OUTCOME MEASURES:

Complication rates, myelopathic severity measured by the Nurick scale, and patient-reported outcomes measured by VAS-neck, VAS-arm, and NDI scores.

METHODS:

We examined patients who underwent either one or two-level ACDF or CDA with a minimum follow-up of 2 years. Patients were matched for age, sex, comorbid conditions, preoperative myelopathy severity, and the number of indicated operative levels. Demographics, perioperative data, and complication rates were compared between the two cohorts of patients. Patient-reported outcome measures were assessed at multiple follow-up intervals.

RESULTS:

No significant differences were observed in demographics or perioperative data. Overall complication rates were similar between the two cohorts (p=.167). Rates of dysphagia (p=1.00), dysphonia (p=.157), infection (p=1.00), construct failure (p=.154), heterotopic ossification (p=.132), and ASD (p=.315) were similar between the two groups. Furthermore, revision rates were similar between the two groups (p=.315). No significant differences were observed in median postoperative Nurick scores between the two cohorts (p=1.00). NDI improvements were greater in the CDA cohort (p=.040).

CONCLUSIONS:

ACDF and CDA had statistically similar complication rates and improvements in myelopathic symptoms. However, patients who underwent CDA had superior PROMs to those who had undergone ACDF.

01 Apr 2025·JOURNAL OF NEUROSURGERY-SPINE

Comparison of outcomes between cervical disc arthroplasty and anterior cervical discectomy and fusion for the treatment of cervical spondylotic myelopathy: a systematic review and meta-analysis

Article

Author: Liao, Jia ; Zhu, JunLang ; Wu, Shuan ; Cai, ZePeng ; Tan, YiMei ; Liu, ShuangHua ; Huang, WeiDong ; Zhang, XuQiao

OBJECTIVE:

The management of cervical spondylotic myelopathy (CSM) presents a clinical conundrum, with cervical disc arthroplasty (CDA) and anterior cervical discectomy and fusion (ACDF) emerging as primary contenders. However, the comparative advantages and limitations of these interventions remain contentious. This meta-analysis aimed to scrutinize the efficacy and safety profiles of CDA and ACDF in addressing CSM.

METHODS:

Adhering rigorously to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, the authors conducted an exhaustive systematic search across reputable databases including PubMed, Embase, Web of Science, Cochrane Library, Scopus, and the Chinese National Knowledge Infrastructure. Randomized controlled trials evaluating the efficacy and safety of CDA versus ACDF for CSM were meticulously selected for comprehensive evaluation.

RESULTS:

A total of 12 randomized controlled trials involving 2612 patients (1464 CDA, 1148 ACDF) were included in this meta-analysis. The pooled results showed that compared with ACDF, CDA was associated with better overall success (RR 1.21, 95% CI 1.06–1.37; p = 0.004; I2 = 71%). In terms of Neck Disability Index and neck visual analog scale (VAS), compared with ACDF, the CDA group showed superior performance at 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery. The performance on the arm VAS at 3 and 12 months after surgery was the same. The operative time for the CDA group was significantly longer than that of the ACDF group. There were no significant differences in neurological success; radiological success; arm VAS scores at 6 weeks, 6 months, and 24 months postoperatively; range of motion; SF-36 mental component summary and physical component summary scores; surgical blood loss; dysphagia/dysphonia; and rate of any adverse event.

CONCLUSIONS:

In contrast to ACDF, CDA exhibited superior clinical efficacy and a more favorable safety profile in the management of CSM. Notably, discernible disparities were observed in the enhancement of neck pain as measured by the VAS within the initial postoperative year. It is imperative to note, however, that the body of evidence supporting these conclusions remains relatively scant, necessitating comprehensive validation through expanded multicenter randomized controlled trials encompassing substantial sample sizes.

100 Deals associated with Artesunate/Chlorproguanil/Dapsone

External Link

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R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Malaria, Falciparum	Phase 3	Burkina Faso	GSK Plc	01 Apr 2006
Malaria, Falciparum	Phase 3	Ghana	GSK Plc	01 Apr 2006
Malaria, Falciparum	Phase 3	Mali	GSK Plc	01 Apr 2006
Malaria, Falciparum	Phase 3	Nigeria	GSK Plc	01 Apr 2006
Malaria	Phase 3	-	The University of Liverpool	-
Malaria	Phase 3	-	MMV Medicines for Malaria Venture	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00344006 (Pubmed \| PLoS One)	Phase 3	Malaria, Falciparum glucose-6-phosphate dehydrogenase (G6PD)	1,372	Chlorproguanil-dapsone-artesunate (CDA)	wwvlnefolq(jnbcduvdjs) = nowqqixsdm xdjcualdjv (ixhqfovecs ) View more	Negative	19 Aug 2009
				Artemether-lumefantrine (AL)	wwvlnefolq(jnbcduvdjs) = ydzhbzwwbs xdjcualdjv (ixhqfovecs ) View more

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