Last reviewed 2026-04-20 · How we verify

Peru-15-pCTB

National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1 active Biologic Quality 0/100

Peru-15-pCTB is a Biologic drug developed by National Institute of Allergy and Infectious Diseases (NIAID). It is currently in Phase 1 development.

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	Peru-15-pCTB
Sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Safety and Immunogenicity of Peru-15-pCTB in Healthy Adult 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:

Peru-15-pCTB CI brief — competitive landscape report
Peru-15-pCTB updates RSS · CI watch RSS
National Institute of Allergy and Infectious Diseases (NIAID) portfolio CI

Frequently asked questions about Peru-15-pCTB

What is Peru-15-pCTB?

Peru-15-pCTB is a Biologic drug developed by National Institute of Allergy and Infectious Diseases (NIAID).

Who makes Peru-15-pCTB?

Peru-15-pCTB is developed by National Institute of Allergy and Infectious Diseases (NIAID) (see full National Institute of Allergy and Infectious Diseases (NIAID) pipeline at /company/national-institute-of-allergy-and-infectious-diseases-niaid).

What development phase is Peru-15-pCTB in?

Peru-15-pCTB is in Phase 1.

Manufacturer: National Institute of Allergy and Infectious Diseases (NIAID) — full pipeline

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