Last reviewed · How we verify
Magic Mouthwash
Magic Mouthwash is a Topical oral rinse combination therapy Small molecule drug developed by Vanderbilt-Ingram Cancer Center. It is currently in Phase 3 development for Chemotherapy-induced oral mucositis, Radiation-induced oral mucositis, Cancer treatment-related oral pain and inflammation. Also known as: Miracle Mouthwash, First-Mouthwash BLM, First-BXN Mouthwash.
Magic Mouthwash is a topical oral rinse that combines local anesthetics, antimicrobials, and anti-inflammatory agents to relieve oral mucositis pain and promote healing in cancer patients.
Magic Mouthwash is used to treat conditions such as mucositis, neoplasms, head and neck cancer, oral mucositis, and oral cavity cancer. It is typically compared to other interventions like Crest Toothpaste and Oral Defense Toothpaste in clinical trials for its effectiveness in healing chemotherapy-induced oral mucositis.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Magic Mouthwash |
|---|---|
| Also known as | Miracle Mouthwash, First-Mouthwash BLM, First-BXN Mouthwash |
| Sponsor | Vanderbilt-Ingram Cancer Center |
| Drug class | Topical oral rinse combination therapy |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Magic Mouthwash typically contains a combination of ingredients such as viscous lidocaine (local anesthetic), diphenhydramine (antihistamine), and magnesium aluminum hydroxide (antacid) or nystatin (antifungal), depending on formulation. These agents work synergistically to numb pain, reduce inflammation, coat damaged mucous membranes, and prevent secondary infections in patients experiencing chemotherapy- or radiation-induced oral mucositis.
Approved indications
- Chemotherapy-induced oral mucositis
- Radiation-induced oral mucositis
- Cancer treatment-related oral pain and inflammation
Common side effects
- Local numbness or altered taste
- Mild gastrointestinal upset if swallowed
- Allergic reaction to components
Key clinical trials
- Effects of Photobiomodulation (PBM) on Pain After Presentation of Aphthous Ulcers in Pediatric Dental Patients (PHASE4)
- Head and Neck Cancer Patients With Oral Mucositis Treated With Ketamine Oral Rinse (PHASE2)
- Effects of Oral Aloe Vera Juice on Chemotherapy and Radiation-induced Oral Mucositis and Esophagitis (PHASE3)
- Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer (PHASE1)
- Gabapentin Compared to Standard of Care in Preventing Mucositis in Patients With Stage III-IV Head and Neck Cancer Undergoing Primary or Adjuvant Chemoradiation Therapy (PHASE3)
- Gelclair at Conditioning or After Oral Mucositis Diagnosed vs. Magic Mouth Wash in Stem Cell Transplant Recipients (PHASE4)
- Effect of Over-the-counter Toothpastes on Chemotherapy-induced Oral Mucositis (PHASE2)
- Morphine Mouthwash for Management of Oral Mucositis in Patients With Head and Neck Cancer (PHASE2, 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:
- Magic Mouthwash CI brief — competitive landscape report
- Magic Mouthwash updates RSS · CI watch RSS
- Vanderbilt-Ingram Cancer Center portfolio CI
Frequently asked questions about Magic Mouthwash
What is Magic Mouthwash?
How does Magic Mouthwash work?
What is Magic Mouthwash used for?
Who makes Magic Mouthwash?
Is Magic Mouthwash also known as anything else?
What drug class is Magic Mouthwash in?
What development phase is Magic Mouthwash in?
What are the side effects of Magic Mouthwash?
Related
- Drug class: All Topical oral rinse combination therapy drugs
- Manufacturer: Vanderbilt-Ingram Cancer Center — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Chemotherapy-induced oral mucositis
- Indication: Drugs for Radiation-induced oral mucositis
- Indication: Drugs for Cancer treatment-related oral pain and inflammation
- Also known as: Miracle Mouthwash, First-Mouthwash BLM, First-BXN Mouthwash
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing