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Placebo (acute phase)
Placebo (acute 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.
Placebo is a small molecule intervention used in clinical trials for various conditions, including Influenza A, Hip Fractures, Acute Ischemic Stroke, Pneumonia, and Non-Infectious Anterior Uveitis. It is a control treatment used in studies, such as a Phase 2 randomized, double-blind, placebo-controlled trial for acute uncomplicated seasonal Influenza A in otherwise healthy adults.
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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 (acute 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 blinded clinical trials to establish baseline efficacy and safety profiles against which active investigational drugs are compared. In this Phase 3 acute phase trial context, placebo allows researchers to distinguish true drug effects from natural disease progression, spontaneous remission, and placebo response effects.
Approved indications
Common side effects
Key clinical trials
- A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome (PHASE3)
- Venetoclax or Placebo in Combination With Reduced-Intensity Conditioning Hematopoietic Cell (Bone Marrow/Blood Stem Cell) Transplant and as Maintenance Therapy After Transplant in Patients With Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial) (PHASE2)
- Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Bipolar I Disorder (PHASE2)
- Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2 (PHASE3)
- Pharmacological and Behavioral Treatment After Bariatric Surgery: Acute (Stage 1) (PHASE2, PHASE3)
- JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record) (PHASE2)
- MP101 in Adults With Acute Pseudomonas Aeruginosa Pneumonia (PHASE1)
- L-Annamycin for Injection in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed AML (PHASE2, 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 (acute phase) CI brief — competitive landscape report
- Placebo (acute phase) updates RSS · CI watch RSS
- ZS Pharma, Inc. portfolio CI
Frequently asked questions about Placebo (acute phase)
What is Placebo (acute phase)?
How does Placebo (acute phase) work?
Who makes Placebo (acute phase)?
Is Placebo (acute phase) also known as anything else?
What development phase is Placebo (acute 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