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OPC-41061
OPC-41061 is a Vasopressin V2 receptor antagonist (vaptан) Small molecule drug developed by Otsuka Pharmaceutical Co., Ltd.. It is currently in Phase 3 development for Hyponatremia associated with heart failure, Hyponatremia associated with cirrhosis, Hyponatremia associated with syndrome of inappropriate antidiuretic hormone secretion (SIADH). Also known as: Tolvaptan.
OPC-41061 is a vasopressin V2 receptor antagonist (vaptан) that blocks water reabsorption in the kidney collecting duct, promoting aquaresis and increasing serum sodium levels.
OPC-41061 is a small molecule that acts as a vasopressin V2 receptor antagonist. It has been studied in clinical trials for various conditions, including Autosomal Dominant Polycystic Kidney Disease, Heart Failure, and Syndrome of Inappropriate Antidiuretic Hormone Secretion.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | OPC-41061 |
|---|---|
| Also known as | Tolvaptan |
| Sponsor | Otsuka Pharmaceutical Co., Ltd. |
| Drug class | Vasopressin V2 receptor antagonist (vaptан) |
| Target | Vasopressin V2 receptor |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular / Nephrology |
| Phase | Phase 3 |
Mechanism of action
By antagonizing the V2 vasopressin receptor on the collecting duct principal cells, OPC-41061 prevents aquaporin-2 water channel insertion and reduces water reabsorption. This leads to increased urine output and free water excretion while retaining sodium, effectively raising serum osmolality and sodium concentration. The drug is used to treat hyponatremia and fluid overload conditions associated with heart failure, cirrhosis, and SIADH.
Approved indications
- Hyponatremia associated with heart failure
- Hyponatremia associated with cirrhosis
- Hyponatremia associated with syndrome of inappropriate antidiuretic hormone secretion (SIADH)
Common side effects
- Thirst
- Dry mouth
- Hypernatremia
- Polyuria
- Dehydration
Key clinical trials
- HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of Life (PHASE3)
- A Study to See Iftolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old withAutosomal Recessive Polycystic Kidney Disease (ARPKD) (PHASE3)
- Probenecid (PB) to Treat Hereditary Nephrogenic Diabetes Insipidus (NDI), ADPKD Treated With Tolvaptan, and Severely Polyuric Patients With Previous Lithium Administration (PHASE2)
- Canadian Medical Assessment of JINARC™ Outcomes Registry
- A Study to See if Tolvaptan Can Delay Dialysis in Infants and Children Who at Enrollment Are 28 Days to Less Than 12 Weeks Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD) (PHASE3)
- Bempedoic Acid Therapy for Polycystic Kidney Disease (PHASE2)
- Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD
- A Study of HRS-9057 in Patients With Heart Failure and Volume Overload (PHASE1)
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:
- OPC-41061 CI brief — competitive landscape report
- OPC-41061 updates RSS · CI watch RSS
- Otsuka Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about OPC-41061
What is OPC-41061?
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Is OPC-41061 also known as anything else?
What drug class is OPC-41061 in?
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What does OPC-41061 target?
Related
- Drug class: All Vasopressin V2 receptor antagonist (vaptан) drugs
- Target: All drugs targeting Vasopressin V2 receptor
- Manufacturer: Otsuka Pharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Cardiovascular / Nephrology
- Indication: Drugs for Hyponatremia associated with heart failure
- Indication: Drugs for Hyponatremia associated with cirrhosis
- Indication: Drugs for Hyponatremia associated with syndrome of inappropriate antidiuretic hormone secretion (SIADH)
- Also known as: Tolvaptan
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing