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ACH-0145228: Powder-in-capsule
ACH-0145228: Powder-in-capsule is a Small molecule drug developed by Alexion Pharmaceuticals, Inc.. It is currently in Phase 1 development. Also known as: ALXN2050.
ACH-0145228 is a small molecule, and it was studied in a clinical trial as an immediate release formulation. The trial focused on healthy participants, with the study examining the effects of a single dose of ACH-0145228 compared to a placebo.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | ACH-0145228: Powder-in-capsule |
|---|---|
| Also known as | ALXN2050 |
| Sponsor | Alexion Pharmaceuticals, Inc. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Study of the Cardiac Effects of ALXN2050 in Healthy Adults (PHASE1)
- A Study to Assess ACH-0145228 When Administered as Immediate Release Tablet Versus Powder-In-Capsule in Healthy Adult Participants (PHASE1)
- A Study of Multiple Doses of ALXN2050 in Healthy Adults (PHASE1)
- A Study of Single-dose ALXN2050 in Healthy Adults (PHASE1)
- A Drug Interaction Study of ACH-0145228 (PHASE1)
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:
- ACH-0145228: Powder-in-capsule CI brief — competitive landscape report
- ACH-0145228: Powder-in-capsule updates RSS · CI watch RSS
- Alexion Pharmaceuticals, Inc. portfolio CI
Frequently asked questions about ACH-0145228: Powder-in-capsule
What is ACH-0145228: Powder-in-capsule?
Who makes ACH-0145228: Powder-in-capsule?
Is ACH-0145228: Powder-in-capsule also known as anything else?
What development phase is ACH-0145228: Powder-in-capsule in?
Related
- Manufacturer: Alexion Pharmaceuticals, Inc. — full pipeline
- Also known as: ALXN2050
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing