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Tiotropium Handihaler
Tiotropium Handihaler is a Small molecule drug developed by Pearl Therapeutics, Inc.. It is currently in Phase 1 development. Also known as: Spiriva.
Tiotropium Handihaler is a medication used to treat Chronic Obstructive Pulmonary Disease (COPD) and other obstructive lung diseases. It works by a mechanism that involves the muscarinic receptor, specifically blocking the action of acetylcholine.
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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 Handihaler |
|---|---|
| Also known as | Spiriva |
| Sponsor | Pearl Therapeutics, Inc. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Chronic obstructive pulmonary
- Nasopharyngitis
- Headache
- Back pain
- Upper respiratory tract infection
- Sinusitis
- Arthralgia
- Hypertension
- Dyspnoea
- Cough
- Diarrhoea
- Pneumonia
Key clinical trials
- Airway Effects of Tiotropium in Patients With COPD (PHASE3)
- Efficacy and Safety of Indacaterol vs Tiotropium in Women With COPD Secondary to Biomass Exposure (PHASE4)
- Assessment of Health-related Quality of Life After Switching COPD Patients From a Dry Powder Inhaler to a Soft Mist Inhaler Remaining on the Same Inhalative Drug
- Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Respimat Device in Patients With Chronic Obstructive Pulmonary Disease (COPD) (PHASE2)
- Phase 4 COPD and Suboptimal Inspiratory Flow Rate (PHASE4)
- Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With Two Reference Products (PHASE1)
- A Trial to Assess the Bioequivalence of Tiotropium Bromide Inhalation Powder in Healthy Adult Participants Under Fasting Conditions (PHASE1)
- Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients After Switching to Tiotropium Plus Olodaterol Fixed Dose Combination in Greece
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 Handihaler CI brief — competitive landscape report
- Tiotropium Handihaler updates RSS · CI watch RSS
- Pearl Therapeutics, Inc. portfolio CI
Frequently asked questions about Tiotropium Handihaler
What is Tiotropium Handihaler?
Who makes Tiotropium Handihaler?
Is Tiotropium Handihaler also known as anything else?
What development phase is Tiotropium Handihaler in?
What are the side effects of Tiotropium Handihaler?
Related
- Manufacturer: Pearl Therapeutics, Inc. — full pipeline
- Also known as: Spiriva
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing