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Difflam
Difflam is a Small molecule drug developed by University of Melbourne. It is currently in Phase 1 development. Also known as: Difflam Soothing Drops + Immune Support Honey & Lemon Flavour.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Difflam |
|---|---|
| Also known as | Difflam Soothing Drops + Immune Support Honey & Lemon Flavour |
| Sponsor | University of Melbourne |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- The Aim of This Study is to Compare the Effects of Two Different Topical Agents (KLOROBEN® and KLORHEX PLUS®) Used in the Surgical Extraction of Mandibular Bilateral Mesioangular Impacted Third Molars on Postoperative Pain, Edema, and Trismus. (NA)
- Benzydamine for Radiation-Induced Oral Mucositis in Patients Receiving High-Dose Radiotherapy (PHASE4)
- The Effect of Supplementary Foods Containing Trypsin, Chymotrypsin and Serratia Peptidase on Healing After Impacted Wisdom Tooth Surgery (NA)
- A Study on Sumac Mouth Rinse for Treating Recurrent Aphthous Stomatitis (NA)
- Palatability Study of Five Formulations of Benzydamine HCl Lozenges (PHASE1)
- A Prospective Study on the Therapeutic Outcomes of Mebo and Tantum Verde in Patients With Oral Mucositis (PHASE3)
- N Acetylcystene in Treatment of Radiotherapy Induced Oral Mucositis in Oral Cancer Patients (NA)
- Study to Evaluate the Efficacy and Safety of Different Doses of Graminidin With Anesthetic, a Metered Dose Topical Spray, in the Treatment of Acute Infectious and Inflammatory Pharyngeal Diseases Compared With Drug Septolete Total, Lozenges (PHASE2)
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:
- Difflam CI brief — competitive landscape report
- Difflam updates RSS · CI watch RSS
- University of Melbourne portfolio CI
Frequently asked questions about Difflam
What is Difflam?
Who makes Difflam?
Is Difflam also known as anything else?
What development phase is Difflam in?
Related
- Manufacturer: University of Melbourne — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Difflam Soothing Drops + Immune Support Honey & Lemon Flavour
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing