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OPC-61815 injection
OPC-61815 injection is a NK1 receptor antagonist Small molecule drug developed by Otsuka Pharmaceutical Co., Ltd.. It is currently in Phase 3 development for Chemotherapy-induced nausea and vomiting (CINV).
OPC-61815 is a selective antagonist of the neurokinin-1 (NK1) receptor that reduces substance P signaling in the central nervous system.
OPC-61815 is a selective antagonist of the neurokinin-1 (NK1) receptor that reduces substance P signaling in the central nervous system. Used for Chemotherapy-induced nausea and vomiting (CINV).
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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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| 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-61815 injection |
|---|---|
| Sponsor | Otsuka Pharmaceutical Co., Ltd. |
| Drug class | NK1 receptor antagonist |
| Target | NK1 receptor (neurokinin-1 receptor) |
| Modality | Small molecule |
| Therapeutic area | Oncology / Supportive Care |
| Phase | Phase 3 |
Mechanism of action
NK1 receptor antagonism blocks the effects of substance P, a neuropeptide involved in pain transmission and emesis. By inhibiting this pathway, OPC-61815 may provide therapeutic benefits in conditions mediated by substance P dysregulation, including chemotherapy-induced nausea and vomiting (CINV) and potentially other neuropsychiatric or pain-related disorders.
Approved indications
- Chemotherapy-induced nausea and vomiting (CINV)
Common side effects
- Headache
- Fatigue
- Constipation
- Diarrhea
Key clinical trials
- OPC-61815 in Healthy Chinese Male Subjects (PHASE1)
- Safety Trial of OPC-61815 Injection in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral Intake (PHASE3)
- Efficacy and Safety Trial of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure (PHASE3)
- Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure (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:
- OPC-61815 injection CI brief — competitive landscape report
- OPC-61815 injection updates RSS · CI watch RSS
- Otsuka Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about OPC-61815 injection
What is OPC-61815 injection?
How does OPC-61815 injection work?
What is OPC-61815 injection used for?
Who makes OPC-61815 injection?
What drug class is OPC-61815 injection in?
What development phase is OPC-61815 injection in?
What are the side effects of OPC-61815 injection?
What does OPC-61815 injection target?
Related
- Drug class: All NK1 receptor antagonist drugs
- Target: All drugs targeting NK1 receptor (neurokinin-1 receptor)
- Manufacturer: Otsuka Pharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology / Supportive Care
- Indication: Drugs for Chemotherapy-induced nausea and vomiting (CINV)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing