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Aerovant
Aerovant is a Small molecule drug developed by Aerovance, Inc.. It is currently in Phase 2 development. Also known as: AER 001 DPI, BAY 16-9996, pitrakinra.
Aerovant, also known as pitrakinra, is a 15-kDa human recombinant protein that acts as an IL-4 and IL-13 antagonist. It has been studied in clinical trials for the treatment of asthma and allergic asthma, including a Phase 1 safety and pharmacokinetics study and a Phase IIb clinical trial.
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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 | Aerovant |
|---|---|
| Also known as | AER 001 DPI, BAY 16-9996, pitrakinra |
| Sponsor | Aerovance, Inc. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study of the Treatment-Sparing Effects of AEROVANT™ AER 001 Inhalation Powder in Asthma Patients, AEROTRIAL (PHASE2)
- A Phase 1 Safety and Pharmacokinetics Study of AER 001 Administered as a Dry Powder in Asthmatic Subjects (PHASE1)
- Effects of AER 001 Administered by Nebulization on Antigen Challenge in Atopic Asthmatics (PHASE2)
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:
- Aerovant CI brief — competitive landscape report
- Aerovant updates RSS · CI watch RSS
- Aerovance, Inc. portfolio CI
Frequently asked questions about Aerovant
What is Aerovant?
Who makes Aerovant?
Is Aerovant also known as anything else?
What development phase is Aerovant in?
Related
- Manufacturer: Aerovance, Inc. — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: AER 001 DPI, BAY 16-9996, pitrakinra
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing