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DFD-03 Lotion, 0.1%
DFD-03 Lotion, 0.1% is a Small molecule drug developed by Dr. Reddy's Laboratories Limited. It is currently in Phase 2 development. Also known as: Tazarotene Lotion, 0.1%.
DFD-03 Lotion, 0.1%, is a topical treatment being studied for the safety and local tolerability in the treatment of Acne Vulgaris. The exact mechanism of DFD-03 Lotion, 0.1%, is currently unknown.
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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 | DFD-03 Lotion, 0.1% |
|---|---|
| Also known as | Tazarotene Lotion, 0.1% |
| Sponsor | Dr. Reddy's Laboratories Limited |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study of the Safety and Efficacy of DFD-03 Lotion in the Treatment of Acne Vulgaris for 12 Weeks (PHASE3)
- A Study of the Safety and Efficacy of DFD-03 for the Treatment of Acne Vulgaris (PHASE3)
- A Bioavailability Study of DFD-03 Compared to Tazorac® in Patients With Moderate Acne Vulgaris (PHASE2)
- A Study to Assess the Safety and Local Tolerability of DFD-03 (Tazarotene) Lotion, 0.1% Compared to Tazorac® Cream, 0.1% in the Topical Treatment of Acne Vulgaris (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:
- DFD-03 Lotion, 0.1% CI brief — competitive landscape report
- DFD-03 Lotion, 0.1% updates RSS · CI watch RSS
- Dr. Reddy's Laboratories Limited portfolio CI
Frequently asked questions about DFD-03 Lotion, 0.1%
What is DFD-03 Lotion, 0.1%?
Who makes DFD-03 Lotion, 0.1%?
Is DFD-03 Lotion, 0.1% also known as anything else?
What development phase is DFD-03 Lotion, 0.1% in?
Related
- Manufacturer: Dr. Reddy's Laboratories Limited — full pipeline
- Also known as: Tazarotene Lotion, 0.1%
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing