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Placebo SLIT-tablet
Placebo SLIT-tablet is a Small molecule drug developed by ALK-Abelló A/S. It is currently in Phase 3 development for Placebo control in phase 3 clinical trials for sublingual immunotherapy.
A placebo sublingual immunotherapy tablet designed to assess efficacy and safety in phase 3 trials by delivering no active therapeutic agent.
Placebo SLIT-tablet is a placebo treatment used in clinical trials for conditions such as allergy, peanut allergy, allergic rhinitis due to grass pollen, and allergic rhinoconjunctivitis. It is a tablet that does not contain any active ingredients, used as a control in studies to compare the efficacy of active treatments.
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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 SLIT-tablet |
|---|---|
| Sponsor | ALK-Abelló A/S |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
This is a placebo control formulation used in clinical trials for sublingual immunotherapy (SLIT). It contains no active allergen or immunological agent and serves as the comparator arm in phase 3 studies to establish the true efficacy of active SLIT-tablet formulations. Placebo tablets are essential for blinded trial design to distinguish genuine therapeutic effects from placebo response.
Approved indications
- Placebo control in phase 3 clinical trials for sublingual immunotherapy
Common side effects
Key clinical trials
- Peanut Sublingual Immunotherapy (SLIT)-Tablet for Treatment of Peanut Allergy (PHASE1, PHASE2)
- A Research Study of House Dust Mite (HDM) SLIT-tablet for the Treatment of HDM Allergy in Chinese Participants Aged 12-65 (PHASE3)
- Grass Pollen Immunotherapy Plus Dupilumab for Tolerance Induction (PHASE2)
- Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic Rhinitis in Adolescents and Children (PHASE3)
- A Study in Children and Adolescents With Birch Pollen-induced Rhinoconjunctivitis (PHASE3)
- Preventing Childhood Asthma Using Prophylactic House Dust Mite Allergen Immunotherapy (PHASE2)
- Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT (PHASE2, PHASE3)
- House Dust Mite Allergy Trial In Children (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 SLIT-tablet CI brief — competitive landscape report
- Placebo SLIT-tablet updates RSS · CI watch RSS
- ALK-Abelló A/S portfolio CI
Frequently asked questions about Placebo SLIT-tablet
What is Placebo SLIT-tablet?
How does Placebo SLIT-tablet work?
What is Placebo SLIT-tablet used for?
Who makes Placebo SLIT-tablet?
What development phase is Placebo SLIT-tablet in?
Related
- Manufacturer: ALK-Abelló A/S — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Placebo control in phase 3 clinical trials for sublingual immunotherapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing