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Placebo, Palonosetron, Dexamethasone
Placebo, Palonosetron, Dexamethasone is a 5-HT3 receptor antagonist + corticosteroid combination Small molecule drug developed by Azienda Ospedaliera di Perugia. It is currently in Phase 3 development for Prevention of chemotherapy-induced nausea and vomiting (CINV) in cancer patients receiving highly emetogenic chemotherapy.
This is a combination regimen using palonosetron (a 5-HT3 antagonist) and dexamethasone (a corticosteroid) to prevent chemotherapy-induced nausea and vomiting, with placebo as a control arm.
This is a combination regimen using palonosetron (a 5-HT3 antagonist) and dexamethasone (a corticosteroid) to prevent chemotherapy-induced nausea and vomiting, with placebo as a control arm. Used for Prevention of chemotherapy-induced nausea and vomiting (CINV) in cancer patients receiving highly emetogenic chemotherapy.
At a glance
| Generic name | Placebo, Palonosetron, Dexamethasone |
|---|---|
| Sponsor | Azienda Ospedaliera di Perugia |
| Drug class | 5-HT3 receptor antagonist + corticosteroid combination |
| Target | 5-HT3 receptor (palonosetron); glucocorticoid receptor (dexamethasone) |
| Modality | Small molecule |
| Therapeutic area | Oncology (supportive care) |
| Phase | Phase 3 |
Mechanism of action
Palonosetron blocks serotonin receptors (5-HT3) in the chemoreceptor trigger zone and gastrointestinal tract to prevent acute nausea and vomiting. Dexamethasone, a glucocorticoid, provides additional antiemetic effects through multiple mechanisms including suppression of inflammatory mediators and enhancement of 5-HT3 antagonist efficacy, particularly for delayed emesis. The combination addresses both acute and delayed chemotherapy-induced nausea and vomiting (CINV).
Approved indications
- Prevention of chemotherapy-induced nausea and vomiting (CINV) in cancer patients receiving highly emetogenic chemotherapy
Common side effects
- Headache
- Constipation
- Diarrhea
- Dizziness
- Insomnia
Key clinical trials
- APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer (PHASE3)
- HR20013 for Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents (PHASE3)
- Treatment of Refractory Nausea and Vomiting in Patients With Breast Cancer (PHASE3)
- Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy (PHASE3)
- Triple Therapy of Dexamethasone, Palonosetron, and Fosaprepitant As PONV Prevention (NA)
- Study to Evaluate the Efficacy and Safety of Plitidepsin in Adults with Post-COVID-19 Condition (PCC) (PHASE2)
- Antiemetic Therapy With or Without Olanzapine in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Cancer Receiving Highly Emetogenic Chemotherapy (PHASE3)
- Aprepitant Triple Therapy for the Prevention of CINV in Nondrinking and Young Women Who Received Moderately Emetogenic Chemotherapy (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Placebo, Palonosetron, Dexamethasone CI brief — competitive landscape report
- Placebo, Palonosetron, Dexamethasone updates RSS · CI watch RSS
- Azienda Ospedaliera di Perugia portfolio CI
Frequently asked questions about Placebo, Palonosetron, Dexamethasone
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Who makes Placebo, Palonosetron, Dexamethasone?
What drug class is Placebo, Palonosetron, Dexamethasone in?
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Related
- Drug class: All 5-HT3 receptor antagonist + corticosteroid combination drugs
- Target: All drugs targeting 5-HT3 receptor (palonosetron); glucocorticoid receptor (dexamethasone)
- Manufacturer: Azienda Ospedaliera di Perugia — full pipeline
- Therapeutic area: All drugs in Oncology (supportive care)
- Indication: Drugs for Prevention of chemotherapy-induced nausea and vomiting (CINV) in cancer patients receiving highly emetogenic chemotherapy
- Compare: Placebo, Palonosetron, Dexamethasone vs similar drugs
- Pricing: Placebo, Palonosetron, Dexamethasone cost, discount & access