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Dry powder mannitol
Dry powder mannitol is a Small molecule drug developed by Syntara. It is currently in Phase 2 development.
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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 | Dry powder mannitol |
|---|---|
| Sponsor | Syntara |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Inhaled Mannitol on Mucociliary Clearance in Moderate to Severe Cystic Fibrosis (PHASE4)
- A Study to Evaluate the Effects for Midface Improvement When Pairing a Biostimulator with a Skincare Regimen (NA)
- A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection. (PHASE2)
- Reference Ranges for the Cough Responsiveness to Inhaled Mannitol (NA)
- Study of RV521 in the Treatment of Adult Subjects Who Have Undergone HCT With an URTI With RSV (PHASE2)
- A Phase 1b Study of PUR1800 in Patients With COPD (PHASE1)
- The Asthma Bronchial Challenge Study
- Norwalk Vaccine Study (PHASE1, 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:
- Dry powder mannitol CI brief — competitive landscape report
- Dry powder mannitol updates RSS · CI watch RSS
- Syntara portfolio CI
Frequently asked questions about Dry powder mannitol
What is Dry powder mannitol?
Who makes Dry powder mannitol?
What development phase is Dry powder mannitol in?
Related
- Manufacturer: Syntara — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing