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Placebo of tolvaptan
A placebo formulation containing no active pharmaceutical ingredient, used as a control comparator in clinical trials of tolvaptan.
Placebo of tolvaptan, marketed by Otsuka Pharmaceutical Co., Ltd., holds a position in the pharmaceutical market with a key composition patent expiring in 2028. The drug's primary strength lies in its established market presence, leveraging Otsuka's reputation and distribution network. The primary risk is the patent expiry in 2028, which could lead to increased competition from generic versions.
At a glance
| Generic name | Placebo of tolvaptan |
|---|---|
| Sponsor | Otsuka Pharmaceutical Co., Ltd. |
| Modality | Small molecule |
| Phase | FDA-approved |
Mechanism of action
Placebo is an inert substance designed to be indistinguishable from the active drug in appearance and administration route. It serves as a control arm in randomized controlled trials to assess the efficacy and safety of tolvaptan by comparison against a non-therapeutic baseline, allowing researchers to isolate the true pharmacological effects of the active drug from placebo response effects.
Approved indications
Common side effects
Key clinical trials
- HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of Life (PHASE3)
- A Phase 2 Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia (PHASE2)
- Acute Heart Failure Patients With High Copeptin Treated With Tolvaptan Targets Increased AVP Activation for Treatment (ACTIVATE) (PHASE3)
- Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease) (PHASE3)
- Tolvaptan-Octreotide LAR Combination in ADPKD (PHASE2)
- Tolvaptan For Worsening Outpatient Heart Failure: Role of Copeptin In Identifying Responders (PHASE4)
- Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With Ascites (PHASE4)
- To Study Effect of the Combination of Midodrine and Tolvaptan Versus Tolvaptan Alone in Patients With Severe Hyponatremia in Cirrhosis(TOLMINA Trial) (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:
- Placebo of tolvaptan CI brief — competitive landscape report
- Placebo of tolvaptan updates RSS · CI watch RSS
- Otsuka Pharmaceutical Co., Ltd. portfolio CI