Last reviewed 2026-06-01 · How we verify

Selexipag encapsulated pellets

Actelion · Phase 1 active Small molecule ✓ Verified Jun 2026

Selexipag encapsulated pellets is a Small molecule drug developed by Actelion. It is currently in Phase 1 development. Also known as: JNJ-67896049.

Selexipag is a small molecule that acts as a prostanoid IP receptor agonist, classified as an agonist drug. It is used in a study for healthy male participants, but its specific indications are not mentioned in the provided facts.

Likelihood of approval

9.6% 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).

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	Selexipag encapsulated pellets
Also known as	JNJ-67896049
Sponsor	Actelion
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study of Selexipag in Healthy Male Participant (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:

Selexipag encapsulated pellets CI brief — competitive landscape report
Selexipag encapsulated pellets updates RSS · CI watch RSS
Actelion portfolio CI

Frequently asked questions about Selexipag encapsulated pellets

What is Selexipag encapsulated pellets?

Selexipag encapsulated pellets is a Small molecule drug developed by Actelion.

Who makes Selexipag encapsulated pellets?

Selexipag encapsulated pellets is developed by Actelion (see full Actelion pipeline at /company/actelion).

Is Selexipag encapsulated pellets also known as anything else?

Selexipag encapsulated pellets is also known as JNJ-67896049.

What development phase is Selexipag encapsulated pellets in?

Selexipag encapsulated pellets is in Phase 1.

Manufacturer: Actelion — full pipeline
Also known as: JNJ-67896049

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