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Pseudoephedrine Pill
Pseudoephedrine Pill is a Small molecule drug developed by John Muir Health. It is currently in Phase 1 development. Also known as: Sudafed.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Pseudoephedrine Pill |
|---|---|
| Also known as | Sudafed |
| Sponsor | John Muir Health |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Barotrauma in Hyperbaric Oxygen Therapy (NA)
- Treatment of Orthostatic Hypotension in Autonomic Failure (PHASE1)
- Effectiveness of Two Preparations of Loratadine + Pseudoephedrine in Patients With Perennial Allergic Rhinitis. (PHASE3)
- The Effect of Ebastine/Pseudoephedrine on Subacute Cough (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:
- Pseudoephedrine Pill CI brief — competitive landscape report
- Pseudoephedrine Pill updates RSS · CI watch RSS
- John Muir Health portfolio CI
Frequently asked questions about Pseudoephedrine Pill
What is Pseudoephedrine Pill?
Who makes Pseudoephedrine Pill?
Is Pseudoephedrine Pill also known as anything else?
What development phase is Pseudoephedrine Pill in?
Related
- Manufacturer: John Muir Health — full pipeline
- Also known as: Sudafed
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing