Last reviewed · How we verify
Placebo/Lactose
Placebo/Lactose is a Small molecule drug developed by University of Manitoba. It is currently in Phase 3 development for Control arm in phase 3 clinical trial (University of Manitoba).
Placebo/lactose has no active pharmacological mechanism and serves as an inert control substance in clinical trials.
Placebo/Lactose is a treatment intervention used in clinical trials, specifically in studies for conditions such as Chronic Obstructive Pulmonary Disease (COPD) and dementia. It is a placebo, which is a substance with no therapeutic effect, made from lactose, a type of sugar.
-
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/Lactose |
|---|---|
| Sponsor | University of Manitoba |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Lactose is a disaccharide sugar used as an inactive comparator in randomized controlled trials to establish baseline efficacy and safety of investigational drugs. It produces no therapeutic effect and allows researchers to distinguish true drug effects from placebo response and natural disease progression.
Approved indications
- Control arm in phase 3 clinical trial (University of Manitoba)
Common side effects
- Adverse events attributable to placebo effect or underlying disease progression
Key clinical trials
- The Effect of NP-2006 on Sleep Quality and Health (NA)
- A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis (PHASE2)
- Maternal Betaine Supplementation During Breastfeeding (PHASE1, PHASE2)
- Psilocybin-assisted Therapy for Treatment of Alcohol Use Disorder (PHASE2)
- Study of Nonsteroidal Anti-inflammatory Drugs in People With Painful Knee Osteoarthritis (PHASE4)
- Efavirenz for the Treatment of Creutzfeldt-Jakob Disease (PHASE3)
- Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening (PHASE4)
- Dual Orexin Antagonism and Emotion and Affective Processing Study (PHASE4)
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/Lactose CI brief — competitive landscape report
- Placebo/Lactose updates RSS · CI watch RSS
- University of Manitoba portfolio CI
Frequently asked questions about Placebo/Lactose
What is Placebo/Lactose?
How does Placebo/Lactose work?
What is Placebo/Lactose used for?
Who makes Placebo/Lactose?
What development phase is Placebo/Lactose in?
What are the side effects of Placebo/Lactose?
Related
- Manufacturer: University of Manitoba — full pipeline
- Indication: Drugs for Control arm in phase 3 clinical trial (University of Manitoba)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing