Last reviewed · How we verify
Placebo + OBR
Placebo + OBR is a Small molecule drug developed by Otsuka Pharmaceutical Development & Commercialization, Inc.. It is currently in Phase 3 development.
This is a placebo control arm combined with OBR (a comparator treatment), used in a Phase 3 clinical trial to establish efficacy and safety baselines.
-
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).
| 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 | Placebo + OBR |
|---|---|
| Sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
In Phase 3 trials, placebo + active comparator arms serve as control groups to demonstrate that an investigational drug performs better than standard care or placebo alone. OBR likely refers to an existing standard-of-care treatment or active comparator. The placebo component isolates the effect of OBR and provides a baseline for assessing the investigational drug's true benefit.
Approved indications
Common side effects
Key clinical trials
- Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance (PHASE2, PHASE3)
- Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy (PHASE2)
- A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD) (PHASE2)
- Study of Epetraborole in Patients With Treatment-refractory MAC Lung Disease (PHASE2, PHASE3)
- Setmelanotide for the Treatment of Leptin Receptor (LEPR) Deficiency Obesity (PHASE3)
- UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection (PHASE3)
- A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB) (PHASE2)
- Effect of Addition of Raltegravir (MK-0518) to PI- or NNRTI-Based ART Regimens in HIV Infected Subjects With Undetectable Viral Load (PHASE2)
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 + OBR CI brief — competitive landscape report
- Placebo + OBR updates RSS · CI watch RSS
- Otsuka Pharmaceutical Development & Commercialization, Inc. portfolio CI
Frequently asked questions about Placebo + OBR
What is Placebo + OBR?
How does Placebo + OBR work?
Who makes Placebo + OBR?
What development phase is Placebo + OBR in?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing