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Reference Product (Spiriva®)
Tiotropium is a long-acting anticholinergic (muscarinic antagonist) that relaxes airway smooth muscle and reduces mucus secretion to improve airflow in chronic obstructive pulmonary disease.
Tiotropium is a long-acting anticholinergic (muscarinic antagonist) that relaxes airway smooth muscle and reduces mucus secretion to improve airflow in chronic obstructive pulmonary disease. Used for Chronic obstructive pulmonary disease (COPD) maintenance treatment, Asthma (in combination with beta-2 agonists).
At a glance
| Generic name | Reference Product (Spiriva®) |
|---|---|
| Sponsor | Lupin, Inc. |
| Drug class | Long-acting muscarinic antagonist (LAMA) |
| Target | M3 muscarinic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Pulmonology |
| Phase | Phase 3 |
Mechanism of action
Tiotropium selectively blocks M3 muscarinic receptors on airway smooth muscle, preventing acetylcholine-induced bronchoconstriction. This produces sustained bronchodilation and reduces mucus production, improving lung function and reducing exacerbations in COPD patients. The drug is inhaled once daily and provides 24-hour coverage.
Approved indications
- Chronic obstructive pulmonary disease (COPD) maintenance treatment
- Asthma (in combination with beta-2 agonists)
Common side effects
- Dry mouth
- Tremor
- Headache
- Pharyngitis
- Urinary retention
Key clinical trials
- A Trial to Assess the Bioequivalence of Tiotropium Bromide Inhalation Powder in Healthy Adult Participants Under Fasting Conditions (PHASE1)
- A Trial to Assess the Bioequivalence of Generic Tiotropium Bromide Inhalation Powder and Reference Product in Healthy Adult Participants Under Fasting Conditions (Pilot) (PHASE1)
- Bioequivalence Study of Tiotropium 18 μg Inhalation Powder, Hard Capsule With Spiriva®Handihaler® 18 μg Inhalation Powder, Hard Capsule in Patients With Chronic Obstructive Pulmonary Disease (COPD) (PHASE3)
- Bioequivalence Study of Tiotropium Bromide Inhalation Powder (PHASE3)
- Clinical Endpoint Bioequivalence Study of Test and Reference Inhalation Products in Patients With COPD With Device Robustness (PHASE3)
- Inspiratory Flow Parameters With Placebo Easyhaler and Placebo HandiHaler (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:
- Reference Product (Spiriva®) CI brief — competitive landscape report
- Reference Product (Spiriva®) updates RSS · CI watch RSS
- Lupin, Inc. portfolio CI