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Placebo ( subacute phase)
Placebo ( subacute phase) is a Small molecule drug developed by ZS Pharma, Inc.. It is currently in Phase 3 development. Also known as: Silicified microcrystalline cellulose.
Placebo produces no pharmacological effect and serves as a control comparator in clinical trials.
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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 ( subacute phase) |
|---|---|
| Also known as | Silicified microcrystalline cellulose |
| Sponsor | ZS Pharma, Inc. |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Placebo is an inert substance administered in the subacute phase of a Phase 3 trial to establish baseline disease progression and distinguish true drug efficacy from natural disease course or observer bias. It allows researchers to measure the actual therapeutic benefit of the investigational agent by comparison to a non-active control.
Approved indications
Common side effects
Key clinical trials
- A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus (PHASE2, PHASE3)
- A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE) (PHASE2)
- A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2) (PHASE3)
- A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (PHASE3)
- A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus (PHASE3)
- A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus (PHASE1)
- Study of ADSTEM Injection for Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis (PHASE3)
- The Effects of Muscle Vibration on the Development of Spasticity and Neuroplasticity in a Post-stroke Population (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 ( subacute phase) CI brief — competitive landscape report
- Placebo ( subacute phase) updates RSS · CI watch RSS
- ZS Pharma, Inc. portfolio CI
Frequently asked questions about Placebo ( subacute phase)
What is Placebo ( subacute phase)?
How does Placebo ( subacute phase) work?
Who makes Placebo ( subacute phase)?
Is Placebo ( subacute phase) also known as anything else?
What development phase is Placebo ( subacute phase) in?
Related
- Manufacturer: ZS Pharma, Inc. — full pipeline
- Also known as: Silicified microcrystalline cellulose
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing