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Mannite
Mannite is a Small molecule drug developed by University Children's Hospital Tuebingen. It is currently in Phase 2 development. Also known as: Mannite Ph. Eur..
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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 | Mannite |
|---|---|
| Also known as | Mannite Ph. Eur. |
| Sponsor | University Children's Hospital Tuebingen |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Effect of Infusion Warming on Mannitol Infusion Pain in Patients With Acute Ocular Hypertension (NA)
- Dose-dependent FODMAP Reintroduction in IBS (NA)
- Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants (PHASE3)
- Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study) (PHASE2)
- Comparison of Changes in Intra-myocardial Amino Acids During Use of Calafiore and Modified Del Nido Cardioplegia
- Safety and Efficacy of AON-D21 in Severe Community-Acquired Pneumonia. (PHASE2)
- Mannitol Versus Nitroglycerin for Kidney Injury Prevention in Robotic-assisted Radical Prostatectomy or Cystectomy (NA)
- Does Caffeine Facilitate Human Reward Learning Behaviors? (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:
- Mannite CI brief — competitive landscape report
- Mannite updates RSS · CI watch RSS
- University Children's Hospital Tuebingen portfolio CI
Frequently asked questions about Mannite
What is Mannite?
Who makes Mannite?
Is Mannite also known as anything else?
What development phase is Mannite in?
Related
- Manufacturer: University Children's Hospital Tuebingen — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Mannite Ph. Eur.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing