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Proflavine, high resolution imaging
Proflavine, high resolution imaging is a Small molecule drug developed by Anandasabapathy, Sharmila, M.D.. It is currently in Phase 2 development. Also known as: Proflavine hemisulfate.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Proflavine, high resolution imaging |
|---|---|
| Also known as | Proflavine hemisulfate |
| Sponsor | Anandasabapathy, Sharmila, M.D. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Effectiveness and Performance of an Optical Biopsy Technology for Esophageal Cancer in Brazil and the United States (PHASE2)
- Precision Optical Guidance for Oral Biopsy (NA)
- Wide-Field and High Resolution In Vivo Imaging in Visualizing Lesions in Patients With Oral Neoplasia Undergoing Surgery (NA)
- Evaluation of Two Non-Invasive Methods, High-Resolution Microendoscopy and Liquid-Based Cytology, for Detection of Oral Precancer (NA)
- Multimodal Imaging for Surveillance in Patients With Oral Potentially Malignant Disorders (EARLY_PHASE1)
- The Effectiveness of High Resolution Microendoscopy for People Living With HIV (PHASE1, PHASE2)
- Low-Cost Imaging for Cervical Cancer Prevention in the Texas Lower Rio Grande Valley (EARLY_PHASE1)
- Use of High-Resolution Microendoscopy (HRME) in Patients With Adenocarcinoma In-Situ (AIS) of the Cervix (NA)
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:
- Proflavine, high resolution imaging CI brief — competitive landscape report
- Proflavine, high resolution imaging updates RSS · CI watch RSS
- Anandasabapathy, Sharmila, M.D. portfolio CI
Frequently asked questions about Proflavine, high resolution imaging
What is Proflavine, high resolution imaging?
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Is Proflavine, high resolution imaging also known as anything else?
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Related
- Manufacturer: Anandasabapathy, Sharmila, M.D. — full pipeline
- Also known as: Proflavine hemisulfate
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing