Last reviewed 2026-04-23 · How we verify

DPT-IPV-Hib

Tanabe Pharma Corporation · Phase 3 active Biologic

DPT-IPV-Hib is a Combination vaccine Biologic drug developed by Tanabe Pharma Corporation. It is currently in Phase 3 development for Primary immunization against diphtheria, pertussis, tetanus, poliomyelitis, and Haemophilus influenzae type b in infants and children. Also known as: BK1310.

DPT-IPV-Hib is a combination vaccine that provides immunization against diphtheria, pertussis, tetanus, poliomyelitis, and Haemophilus influenzae type b through inactivated pathogen antigens and toxoids. Used for Primary immunization against diphtheria, pertussis, tetanus, poliomyelitis, and Haemophilus influenzae type b in infants and children.

Likelihood of approval

59.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	DPT-IPV-Hib
Also known as	BK1310
Sponsor	Tanabe Pharma Corporation
Drug class	Combination vaccine
Modality	Biologic
Therapeutic area	Immunology / Infectious Disease Prevention
Phase	Phase 3

Mechanism of action

This pentavalent vaccine contains diphtheria and tetanus toxoids, acellular pertussis antigens, inactivated poliovirus antigens, and Haemophilus influenzae type b conjugate antigen. Each component stimulates the immune system to produce antibodies and cellular immunity against these five pathogens, providing protection against the corresponding infectious diseases.

Approved indications

Primary immunization against diphtheria, pertussis, tetanus, poliomyelitis, and Haemophilus influenzae type b in infants and children

Common side effects

Injection site reactions (pain, redness, swelling)
Fever
Irritability
Drowsiness

Key clinical trials

Exploratory Clinical Study of MT-2301 (PHASE2)
Phase 3 Study of BK1310 in Healthy Infants (PHASE3)
Confirmatory Study of BK1310 in Healthy Infants (PHASE3)
Safety and Efficacy of BK1310 Intramuscular Injection in Healthy Infants (PHASE3)

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:

DPT-IPV-Hib CI brief — competitive landscape report
DPT-IPV-Hib updates RSS · CI watch RSS
Tanabe Pharma Corporation portfolio CI

Frequently asked questions about DPT-IPV-Hib

What is DPT-IPV-Hib?

DPT-IPV-Hib is a Combination vaccine drug developed by Tanabe Pharma Corporation, indicated for Primary immunization against diphtheria, pertussis, tetanus, poliomyelitis, and Haemophilus influenzae type b in infants and children.

How does DPT-IPV-Hib work?

What is DPT-IPV-Hib used for?

DPT-IPV-Hib is indicated for Primary immunization against diphtheria, pertussis, tetanus, poliomyelitis, and Haemophilus influenzae type b in infants and children.

Who makes DPT-IPV-Hib?

DPT-IPV-Hib is developed by Tanabe Pharma Corporation (see full Tanabe Pharma Corporation pipeline at /company/tanabe-pharma-corporation).

Is DPT-IPV-Hib also known as anything else?

DPT-IPV-Hib is also known as BK1310.

What drug class is DPT-IPV-Hib in?

DPT-IPV-Hib belongs to the Combination vaccine class. See all Combination vaccine drugs at /class/combination-vaccine.

What development phase is DPT-IPV-Hib in?

DPT-IPV-Hib is in Phase 3.

What are the side effects of DPT-IPV-Hib?

Common side effects of DPT-IPV-Hib include Injection site reactions (pain, redness, swelling), Fever, Irritability, Drowsiness.

Drug class: All Combination vaccine drugs
Manufacturer: Tanabe Pharma Corporation — full pipeline
Therapeutic area: All drugs in Immunology / Infectious Disease Prevention
Indication: Drugs for Primary immunization against diphtheria, pertussis, tetanus, poliomyelitis, and Haemophilus influenzae type b in infants and children
Also known as: BK1310

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