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Replens
Replens is a Small molecule drug developed by Polly A. Niravath, MD. It is currently in Phase 2 development.
Replens is a moisturizer used for protecting, moisturizing, and lubricating the skin. It is a type of emollient that helps to soften the skin, typically by mimicking the functions of sebum produced by healthy skin.
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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 | Replens |
|---|---|
| Sponsor | Polly A. Niravath, MD |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Chronic Ingestion of Fructooligosaccharide and Psyllium on Intestinal Transit in Women With Functional Constipation: A Randomized Crossover Trial (NA)
- Exploring Mechanism of Action of Dietary Fibre on the Gut Microbiota and Metabolites (NA)
- REVIVE: Replens Versus Intra-Vaginal Estrogen for the Treatment of Vaginal Dryness on Aromatase Inhibitor Therapy (PHASE2)
- CHRONO-NUTRITION APPLICATION: THE EFFECT OF FIBER JELLY ON POST PRANDIAL BLOOD GLUCOSE, SATIETY AND WEIGHT LOSS AMONG OVERWEIGHT WOMEN (NA)
- Milk Thistle Clinical Trial in Pediatric NAFLD (PHASE2)
- Psyllium in Pediatric IBS (PHASE2)
- A Trial to Assess Gastrointestinal Responses to Dietary Fibers in Adults Using Weight Loss Medications (NA)
- Ovolux Beauty From Within Trial#2 (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:
- Replens CI brief — competitive landscape report
- Replens updates RSS · CI watch RSS
- Polly A. Niravath, MD portfolio CI
Frequently asked questions about Replens
What is Replens?
Who makes Replens?
What development phase is Replens in?
Related
- Manufacturer: Polly A. Niravath, MD — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing