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tiotropium pMDI
tiotropium pMDI is a Small molecule drug developed by Solventum US LLC. It is currently in Phase 1 development. Also known as: Spiriva Respimat.
Tiotropium pMDI is a small molecule that acts as a muscarinic acetylcholine receptor M3 antagonist. It is used to treat conditions such as COPD and asthma, and has been studied in clinical trials for its efficacy in these conditions.
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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 | tiotropium pMDI |
|---|---|
| Also known as | Spiriva Respimat |
| Sponsor | Solventum US LLC |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Two-period 21 Day Cross-over Study to Compare the Pharmacokinetics of Tiotropium From Two Inhalers (PHASE1)
- Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With A Reference Product (EARLY_PHASE1)
- Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With Reference (PHASE1)
- Effect on Bronchodilation Response and Ventilation Heterogeneity of Different Inhalation Volumes in COPD
- Non Inferiority of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) Versus Combination of Fluticasone Furoate (FlF)/Vilanterol (VI) + Tiotropium Bromide in Chronic Obstructive Pulmonary Disease (COPD) (PHASE3)
- Safety and Efficacy Study of Glyco pMDI After Single and Repeated Administration (PHASE1, PHASE2)
- Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate in Chronic Obstructive Pulmonary Disease (PHASE3)
- A 6-week Dose Ranging Study of CHF 5259 pMDI in Subjects With Chronic Obstructive Pulmonary Disease (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:
- tiotropium pMDI CI brief — competitive landscape report
- tiotropium pMDI updates RSS · CI watch RSS
- Solventum US LLC portfolio CI
Frequently asked questions about tiotropium pMDI
What is tiotropium pMDI?
Who makes tiotropium pMDI?
Is tiotropium pMDI also known as anything else?
What development phase is tiotropium pMDI in?
Related
- Manufacturer: Solventum US LLC — full pipeline
- Also known as: Spiriva Respimat
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing