Last reviewed 2026-05-31 · How we verify

PN-881 Oral Solution

Protagonist Therapeutics, Inc. · Phase 1 active Small molecule ✓ Verified May 2026

PN-881 Oral Solution is a Small molecule drug developed by Protagonist Therapeutics, Inc.. It is currently in Phase 1 development.

PN-881 Oral Solution is being studied in a clinical trial to assess its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy subjects. The study, NCT07153146, is a randomized, double-blind, placebo-controlled trial that involves single and multiple ascending doses of PN-881 Oral Solution, as well as PN-881 Oral Tablet and placebo.

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	PN-881 Oral Solution
Sponsor	Protagonist Therapeutics, Inc.
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PN-881 in Healthy Subjects. (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:

PN-881 Oral Solution CI brief — competitive landscape report
PN-881 Oral Solution updates RSS · CI watch RSS
Protagonist Therapeutics, Inc. portfolio CI

Frequently asked questions about PN-881 Oral Solution

What is PN-881 Oral Solution?

PN-881 Oral Solution is a Small molecule drug developed by Protagonist Therapeutics, Inc..

Who makes PN-881 Oral Solution?

PN-881 Oral Solution is developed by Protagonist Therapeutics, Inc. (see full Protagonist Therapeutics, Inc. pipeline at /company/protagonist-therapeutics-inc).

What development phase is PN-881 Oral Solution in?

PN-881 Oral Solution is in Phase 1.

Manufacturer: Protagonist Therapeutics, Inc. — full pipeline

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