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Placebo + SOC
Placebo + SOC is a Small molecule drug developed by 101 Therapeutics. It is currently in Phase 3 development. Also known as: Placebo + Standard of Care.
Placebo combined with standard of care provides a control comparator in clinical trials to assess the incremental benefit of an investigational therapy.
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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).
| 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 + SOC |
|---|---|
| Also known as | Placebo + Standard of Care |
| Sponsor | 101 Therapeutics |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
This is a control arm designation rather than an active drug. It represents the baseline treatment (standard of care) plus an inert placebo, used in phase 3 trials to establish efficacy and safety of the experimental agent by comparison. The specific mechanism depends entirely on what the standard of care regimen includes for the indication being studied.
Approved indications
Common side effects
Key clinical trials
- MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) (PHASE2)
- Study to Evaluate the Long-Term Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Subjects With GPP (PHASE3)
- Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy, URO-PRO Trial (PHASE2)
- Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome (PHASE2)
- A Study of Brenipatide in Adult Participants With Schizophrenia (PHASE2)
- Study of Nogapendekin Alfa Inbakicept and iNKT Cells in Critically Ill Adults With Severe Community-Acquired Pneumonia (PHASE3)
- A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis (PHASE2)
- A Study of Brenipatide in Adult Participants With Major Depressive Disorder (PHASE3)
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 + SOC CI brief — competitive landscape report
- Placebo + SOC updates RSS · CI watch RSS
- 101 Therapeutics portfolio CI
Frequently asked questions about Placebo + SOC
What is Placebo + SOC?
How does Placebo + SOC work?
Who makes Placebo + SOC?
Is Placebo + SOC also known as anything else?
What development phase is Placebo + SOC in?
Related
- Manufacturer: 101 Therapeutics — full pipeline
- Also known as: Placebo + Standard of Care
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing