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Apremilast Modified Release 14
Apremilast Modified Release 14 is a PDE4 inhibitor Small molecule drug developed by Amgen. It is currently in Phase 1 development.
Inhibits phosphodiesterase-4 (PDE4), reducing inflammatory mediators by increasing intracellular cyclic AMP levels.
Apremilast Modified Release 14 is a small molecule that inhibits phosphodiesterase 4. It is being studied in clinical trials for conditions including COVID-19 and as a treatment option in addition to standard of care.
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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). -
Big-pharma sponsor
+3.0pp
Amgen is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Apremilast Modified Release 14 |
|---|---|
| Sponsor | Amgen |
| Drug class | PDE4 inhibitor |
| Modality | Small molecule |
| Phase | Phase 1 |
Mechanism of action
By inhibiting PDE4, apremilast increases intracellular cyclic adenosine monophosphate (cAMP) levels, which modulates the production of pro-inflammatory and anti-inflammatory mediators. This mechanism helps reduce inflammation in various immune-mediated conditions.
Approved indications
Common side effects
Key clinical trials
- I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients (PHASE2)
- Study of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients (PHASE3)
- Study to Evaluate Pharmacokinetics of Prototype Modified-Release Formulations Of Apremilast in Healthy Men (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:
- Apremilast Modified Release 14 CI brief — competitive landscape report
- Apremilast Modified Release 14 updates RSS · CI watch RSS
- Amgen portfolio CI
Frequently asked questions about Apremilast Modified Release 14
What is Apremilast Modified Release 14?
How does Apremilast Modified Release 14 work?
Who makes Apremilast Modified Release 14?
What drug class is Apremilast Modified Release 14 in?
What development phase is Apremilast Modified Release 14 in?
Related
- Drug class: All PDE4 inhibitor drugs
- Manufacturer: Amgen — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing