Last reviewed 2026-05-19 · How we verify

Apremilast Modified Release 4

Amgen · Phase 1 active Small molecule ✓ Verified May 2026 Quality 15/100

Apremilast Modified Release 4 is a Small molecule drug developed by Amgen. It is currently in Phase 1 development.

Apremilast Modified Release 4 is a small molecule that inhibits phosphodiesterase 4. It is being studied in clinical trials for various conditions, including COVID-19 and as a treatment for hospitalized patients.

Likelihood of approval

12.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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 4
Sponsor	Amgen
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

HEADACHE
NAUSEA
ERYTHEMA
CONJUNCTIVAL HYPERAEMIA
VISION BLURRED
ABDOMINAL DISCOMFORT
ABDOMINAL PAIN UPPER
CHANGE OF BOWEL HABIT
DIARRHOEA
DRY MOUTH
HAEMORRHOIDS
FOLLICULITIS

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:

Apremilast Modified Release 4 CI brief — competitive landscape report
Apremilast Modified Release 4 updates RSS · CI watch RSS
Amgen portfolio CI

Frequently asked questions about Apremilast Modified Release 4

What is Apremilast Modified Release 4?

Apremilast Modified Release 4 is a Small molecule drug developed by Amgen.

Who makes Apremilast Modified Release 4?

Apremilast Modified Release 4 is developed by Amgen (see full Amgen pipeline at /company/amgen).

What development phase is Apremilast Modified Release 4 in?

Apremilast Modified Release 4 is in Phase 1.

What are the side effects of Apremilast Modified Release 4?

Common side effects of Apremilast Modified Release 4 include HEADACHE, NAUSEA, ERYTHEMA, CONJUNCTIVAL HYPERAEMIA, VISION BLURRED, ABDOMINAL DISCOMFORT.

Manufacturer: Amgen — full pipeline

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing