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AD109 dose1- A
AD109 dose1- A is a orexin receptor antagonist Small molecule drug developed by Apnimed. It is currently in Phase 2 development for Narcolepsy. Also known as: AD109 75.
AD109 is a small molecule that targets the orexin receptor to treat narcolepsy.
AD109 is a small molecule that targets the orexin receptor to treat narcolepsy. Used for Narcolepsy.
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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). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| 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 | AD109 dose1- A |
|---|---|
| Also known as | AD109 75 |
| Sponsor | Apnimed |
| Drug class | orexin receptor antagonist |
| Target | orexin receptor |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 2 |
Mechanism of action
AD109 works by selectively binding to the orexin receptor, which is involved in regulating sleep-wake cycles. This binding action helps to reduce excessive daytime sleepiness and other symptoms associated with narcolepsy. By modulating the orexin system, AD109 aims to restore normal sleep-wake patterns.
Approved indications
- Narcolepsy
Common side effects
- Headache
- Nausea
- Dizziness
Key clinical trials
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:
- AD109 dose1- A CI brief — competitive landscape report
- AD109 dose1- A updates RSS · CI watch RSS
- Apnimed portfolio CI
Frequently asked questions about AD109 dose1- A
What is AD109 dose1- A?
How does AD109 dose1- A work?
What is AD109 dose1- A used for?
Who makes AD109 dose1- A?
Is AD109 dose1- A also known as anything else?
What drug class is AD109 dose1- A in?
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What are the side effects of AD109 dose1- A?
What does AD109 dose1- A target?
Related
- Drug class: All orexin receptor antagonist drugs
- Target: All drugs targeting orexin receptor
- Manufacturer: Apnimed — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Narcolepsy
- Also known as: AD109 75
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing