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Placebo Comparator: Arm B - Control
Placebo Comparator: Arm B - Control is a Small molecule drug developed by Syntara. It is currently in Phase 3 development.
A placebo comparator arm provides no active therapeutic intervention and serves as a control baseline in clinical trials.
Arm B of the Placebo Comparator is a control group that receives a placebo, and it is used in clinical trials studying various conditions such as Diabetes Mellitus, Type 1, and Irritable Bowel Syndrome With Diarrhea. The control group is also used in trials involving traumatic brain injury and brain conditions, and it is administered via closed-loop (CL) or other methods, such as insulin monotherapy or sitagliptin.
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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 Comparator: Arm B - Control |
|---|---|
| Sponsor | Syntara |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Placebo comparators are inert substances or sham procedures used in randomized controlled trials to establish the efficacy of an investigational drug by comparison. They help distinguish genuine drug effects from natural disease progression, regression to the mean, and placebo response. This is a standard control arm rather than an active pharmaceutical agent.
Approved indications
Common side effects
Key clinical trials
- Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy (PHASE3)
- "A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder" (PHASE3)
- 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 Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Children With Moderate to Severe Chronic Plaque Psoriasis (PHASE3)
- A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate to Severe Chronic Obstructive Pulmonary Disease (PHASE2, PHASE3)
- A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity (PHASE2)
- 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)
- A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer. (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 Comparator: Arm B - Control CI brief — competitive landscape report
- Placebo Comparator: Arm B - Control updates RSS · CI watch RSS
- Syntara portfolio CI
Frequently asked questions about Placebo Comparator: Arm B - Control
What is Placebo Comparator: Arm B - Control?
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Who makes Placebo Comparator: Arm B - Control?
What development phase is Placebo Comparator: Arm B - Control in?
Related
- Manufacturer: Syntara — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing