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AR101 powder provided in capsules
AR101 powder provided in capsules is a oral immunotherapy Biologic drug developed by Aimmune Therapeutics, Inc.. It is currently in Phase 2 development for Peanut allergy.
AR101 is an oral immunotherapy for peanut allergy.
AR101 powder is a treatment provided in capsules for peanut allergy, as studied in clinical trials such as the ARTEMIS trial. The exact mechanism of AR101 powder is unknown, according to ChEMBL.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | AR101 powder provided in capsules |
|---|---|
| Sponsor | Aimmune Therapeutics, Inc. |
| Drug class | oral immunotherapy |
| Modality | Biologic |
| Therapeutic area | Allergy |
| Phase | Phase 2 |
Mechanism of action
AR101 works by gradually increasing tolerance to peanut protein through the ingestion of small, controlled amounts of peanut flour. This is achieved through a process called desensitization, where the body becomes less reactive to the presence of peanuts over time.
Approved indications
- Peanut allergy
Common side effects
- Gastrointestinal symptoms
- Anaphylaxis
Key clinical trials
- Peanut Oral Immunotherapy Study of Early Intervention for Desensitization (PHASE3)
- Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE) (PHASE3)
- PALISADE Follow-on Study (ARC004) (PHASE3)
- Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen OIT (PHASE2)
- Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES) (PHASE3)
- ARTEMIS Peanut Allergy 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:
- AR101 powder provided in capsules CI brief — competitive landscape report
- AR101 powder provided in capsules updates RSS · CI watch RSS
- Aimmune Therapeutics, Inc. portfolio CI
Frequently asked questions about AR101 powder provided in capsules
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Related
- Drug class: All oral immunotherapy drugs
- Manufacturer: Aimmune Therapeutics, Inc. — full pipeline
- Therapeutic area: All drugs in Allergy
- Indication: Drugs for Peanut allergy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing