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Takeda

Takeda is a pharma organization headquartered in Cambridge, USA. Primary therapeutic focus areas include Diabetes Mellitus, Hemophilia A, Crohn's Disease, Hypertension, Type 2 Diabetes Mellitus. NovaPharmaNews links 1179

Cambridge, USA HQ
1993 Founded
1,617 Employees
NMPA registrant Type
Company details
Clinical program

Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)

Phase 2 · mab · Poliomyelitis

Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV), internal code IPV-102, is a vaccine candidate developed by Takeda for the prevention of poliomyelitis. The program is based on inactivated poliovirus derived from Sabin strains and represents part of Takeda's broader vaccine portfolio strategy. As of the latest disc

← All Takeda projects Phase 2 mab terminated

Internal code IPV-102

At a glance

Sponsor
Takeda
Phase
Phase 2
Modality
mab
Indication
Poliomyelitis
Status
terminated
Trials
1

Executive summary

Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV), internal code IPV-102, is a vaccine candidate developed by Takeda for the prevention of poliomyelitis. The program is based on inactivated poliovirus derived from Sabin strains and represents part of Takeda's broader vaccine portfolio strategy. As of the latest disclosed milestone on 31 January 2020, the program has been terminated and is no longer in active development. The program had advanced to Phase 2 clinical evaluation, with clinical trial activity documented under NCT03092791. No mechanism of action, target designation, or lead investigator information has been disclosed. Regulatory approval status across major jurisdictions (FDA, EMA, PMDA, NMPA) has not been disclosed, consistent with the program's terminated status. The termination represents a strategic decision by Takeda to redirect resources, though the specific rationale for discontinuation has not been publicly detailed in the available facts.

Analyst view

Why this program matters

Poliomyelitis remains a significant global public health concern despite decades of vaccination campaigns. While wild poliovirus transmission has been nearly eliminated in most regions, the disease continues to pose risks in areas with incomplete immunization coverage and in populations vulnerable to vaccine-derived poliovirus (VDPV). Enhanced inactivated polio vaccines (IPV) offer potential advantages over oral polio vaccine (OPV) formulations, including elimination of VDPV risk and suitability for immunocompromised populations. Sabin-based inactivated formulations represent a technological refinement in polio prevention, potentially offering improved immunogenicity or manufacturing efficiency compared to conventional wild-type IPV. The competitive landscape includes established combination vaccines such as INFANRIX HEXA (containing IPV component) and other hexavalent formulations, indicating sustained market demand for integrated immunization solutions. The termination of sIPV suggests that Takeda's strategic priorities shifted away from standalone or novel polio vaccine development, possibly due to market saturation, manufacturing complexity, or reallocation toward higher-priority vaccine programs such as QDENGA (dengue vaccine, approved). The program's discontinuation does not diminish the ongoing clinical and commercial relevance of polio vaccination globally, particularly in endemic and at-risk regions.

Drug intelligence

Drug Class: Inactivated viral vaccine (poliomyelitis)

Modality: Vaccine (biological)

Mechanism of Action: Not disclosed; presumed to induce humoral and cellular immune responses against poliovirus antigens derived from Sabin strains

Molecular Type: Inactivated poliovirus vaccine based on Sabin strain(s)

Route of Administration: Not disclosed; presumed intramuscular injection consistent with standard IPV administration

Target: Poliovirus (types 1, 2, and/or 3); specific serotype coverage not disclosed

Related Therapies: INFANRIX HEXA (hexavalent combination vaccine containing IPV component, approved by EMA); HEXYON (hexavalent vaccine); conventional wild-type inactivated polio vaccines (IPV); oral polio vaccine (OPV) formulations

First Approval: Not achieved; program terminated prior to regulatory approval

Patent Status: Not disclosed

Disease intelligence

poliomyelitis

Also known as: Polia, acute poliomyelitis, polio, infantile paralysis

Prevalence: Point prevalence: <1 / 1 000 000 (Europe) — source: Orphanet, not yet validated.

Overview

An acute infectious disorder that affects the nervous system. It is caused by the poliovirus. The virus spreads by direct contact, and can be prevented by prophylaxis with the polio vaccine.

Treatment landscape

ClinicalTrials.gov lists 189 registered studies for Poliomyelitis (AACT aggregate).

Phase breakdown: PHASE3 (75), PHASE4 (45), PHASE2 (28), NA (21), PHASE1 (11), PHASE1/PHASE2 (5), PHASE2/PHASE3 (4)

Common investigational therapies:

  • IPV
  • Inactivated Poliomyelitis Vaccine (Sabin strains)
  • Infanrix hexa
  • Infanrix hexa™
  • GSK2202083A vaccine
  • sIPV
  • Polysaccharide Diphtheria Toxoid Conjugate Vaccine
  • IPV-Al SSI
  • nOPV2
  • DTaP-HepB-IPV-Hib vaccine
Classification: MONDO MONDO:0017373 ORPHA 2912 MeSH D011051

Disease data sourced from MONDO Disease Ontology (MONDO:0017373), Orphanet — poliomyelitis, NCT00001185, NCT00092469, NCT00133445, NCT00137696, NCT00138268, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, Open Targets Platform (CC BY 4.0).

Clinical development timeline

  1. Phase 2TBD

    Phase 2 clinical development

    Program advanced to Phase 2 evaluation; specific trial initiation date not disclosed.

  2. Discovery2020-01-31

    Program terminated

    Latest disclosed milestone indicates program termination as of 31 January 2020; no subsequent development activity reported.

Competitive landscape

The polio vaccine competitive landscape is dominated by established combination vaccine formulations and conventional inactivated polio vaccines (IPV). INFANRIX HEXA, manufactured by GlaxoSmithKline Biologicals S.A. and approved by the EMA (authorization date 12 February 2026, EMEA/H/C/000296), represents the primary direct competitor as a hexavalent vaccine incorporating IPV alongside diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type-b components. HEXYON represents an alternative hexavalent formulation. Takeda itself markets QDENGA (dengue vaccine, approved), demonstrating the company's continued vaccine development and commercialization capabilities in other therapeutic areas. The termination of sIPV suggests that Takeda determined the competitive and regulatory barriers to market entry for a novel or improved polio vaccine formulation were prohibitive relative to the commercial opportunity. The facts list additional vaccine competitors (TRITANRIX HEPB, M-M-RVAXPRO, FLUCELVAX, VAXCHORA, IXCHIQ, COVID-19 VACCINE VALNEVA, FOCETRIA, MRESVIA, COMIRNATY, MCOMBRIAX) representing diverse vaccine modalities and indications, reflecting the broad competitive environment in which Takeda operates. The established market position of GlaxoSmithKline and other manufacturers in combination vaccines, coupled with the near-elimination of wild poliovirus in most regions, likely contributed to Takeda's strategic decision to discontinue sIPV development.

TherapyCompanyMechanismStatus
MRESVIATeva Pharma GmbHFusion glycoprotein F0 vaccine antigenapproved
COMIRNATYTeva Pharma GmbHSpike glycoprotein vaccine antigenapproved
QDENGATakedaBiological vaccine - induces immune responseapproved
MCOMBRIAXTeva Pharma GmbHapproved
TRITANRIX HEPBapproved
M-M-RVAXPROapproved
FLUCELVAXapproved
VAXCHORABiological vaccine - induces immune responseapproved
IXCHIQBiological vaccine - induces immune responseapproved
COVID-19 VACCINE (INACTIVATED, ADJUVANTED) VALNEVABiological vaccine - induces immune responseapproved
FOCETRIAapproved
HEXYONapproved
NOREPINEPHRINE BITARTRATEAdrenergic receptor agonistApproved
MODAFINILDopamine transporter inhibitorPhase 3

Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.

Regulatory intelligence

FDA (United States): Regulatory status not disclosed. No approval or filing information available in the facts.

EMA (European Union): Regulatory status not disclosed for sIPV. INFANRIX HEXA (containing IPV component) is approved by the EMA with authorization date 12 February 2026 (EMEA/H/C/000296), manufactured by GlaxoSmithKline Biologicals S.A., demonstrating established regulatory pathways for IPV-containing vaccines in Europe.

PMDA (Japan): Regulatory status not disclosed.

NMPA (China): Multiple inactivated and vaccine formulations are documented in clinical trials in China (NCT01244464, NCT03001986, NCT05148949, NCT05198336, NCT05365724 for inactivated formulations; NCT01507857, NCT02003495, NCT02302170, NCT03357289, NCT07077356 for vaccine formulations), indicating active vaccine development activity in the Chinese market. sIPV-specific regulatory status in China not disclosed.

Program Status: Terminated as of 31 January 2020. No regulatory filings or approvals achieved prior to termination.

Clinical evidence summary

NCT03092791

Objective
Objective not disclosed in available facts.
Design
Design not disclosed; trial associated with sIPV Phase 2 development.
Participants
Participant population not disclosed.
Primary endpoint
Primary endpoint not disclosed.
Results
Results not yet reported or not disclosed in available facts.

Key questions answered

What is Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)?

sIPV is a vaccine candidate developed by Takeda for prevention of poliomyelitis, based on inactivated poliovirus derived from Sabin strains. The program was terminated in January 2020 and is no longer in active development.

What is the indication for sIPV?

The indication is poliomyelitis prevention. sIPV was intended for immunization against poliovirus, though the specific serotype coverage (types 1, 2, and/or 3) is not disclosed.

Who is developing sIPV?

Takeda is the sponsor and developer of sIPV. No partner or co-developer is identified in the available facts.

What is the current development status of sIPV?

sIPV development has been terminated as of 31 January 2020. The program is no longer active and no further development is anticipated.

What phase of development was sIPV in when terminated?

sIPV had advanced to Phase 2 clinical development prior to termination. No Phase 3 trials were initiated.

Is sIPV approved by the FDA?

No. sIPV was not approved by the FDA. The program was terminated prior to regulatory filing or approval.

Is sIPV approved by the EMA?

No. sIPV was not approved by the EMA. The program was terminated prior to regulatory approval in Europe.

What is the mechanism of action of sIPV?

The specific mechanism of action is not disclosed. As an inactivated vaccine, sIPV is presumed to induce humoral and cellular immune responses against poliovirus antigens derived from Sabin strains.

What is the modality of sIPV?

sIPV is classified as a vaccine, specifically an inactivated viral vaccine (biological modality).

What clinical trial is associated with sIPV?

NCT03092791 is the clinical trial identifier associated with sIPV Phase 2 development. Specific trial details (design, endpoints, results) are not disclosed in available facts.

What are the main competitors to sIPV in the polio vaccine market?

INFANRIX HEXA (GlaxoSmithKline, approved by EMA) and HEXYON are established hexavalent vaccines containing IPV components. Conventional wild-type inactivated polio vaccines (IPV) and oral polio vaccine (OPV) formulations also compete in the polio prevention market.

Why was sIPV terminated?

The specific rationale for termination is not disclosed in available facts. Likely factors include competitive pressures from established manufacturers, regulatory complexity, market saturation in polio vaccines, and Takeda's strategic reallocation of resources toward higher-priority vaccine programs such as QDENGA (dengue vaccine).

What is the route of administration for sIPV?

The route of administration is not explicitly disclosed. As an inactivated polio vaccine, sIPV is presumed to be administered via intramuscular injection, consistent with standard IPV formulations.

Is sIPV a combination vaccine?

The facts do not indicate whether sIPV was formulated as a standalone vaccine or as part of a combination vaccine. INFANRIX HEXA, a competing product, is a hexavalent combination vaccine.

What is Takeda's current vaccine portfolio strategy?

Takeda's vaccine portfolio includes approved products such as QDENGA (dengue vaccine). The termination of sIPV suggests Takeda is prioritizing vaccine programs with higher commercial potential and growth prospects in therapeutic areas beyond polio prevention.

Are there any ongoing clinical trials for sIPV?

No. The program was terminated in January 2020, and no ongoing clinical trials for sIPV are anticipated. NCT03092791 is the only trial identifier associated with the program.

Entity relationship graph

Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV) → Drug → Target → Indication → Company → Trials → Competitors

Evidence-based

Analyst insights

Strategic Implications: Takeda's termination of sIPV in January 2020 reflects a strategic pivot away from novel polio vaccine development. The decision likely reflects portfolio optimization, with Takeda prioritizing higher-value vaccine programs such as QDENGA (dengue vaccine, approved and commercialized) and other therapeutic areas. The near-elimination of wild poliovirus globally constrains market growth for polio vaccines, limiting commercial incentives for novel formulation development. Regulatory pathways for demonstrating non-inferiority or superiority over established IPV formulations present significant barriers to entry, particularly given the entrenched market positions of GlaxoSmithKline (INFANRIX HEXA) and other manufacturers.

Competitive Implications: The termination eliminates sIPV as a potential competitive threat to established IPV manufacturers. GlaxoSmithKline's INFANRIX HEXA and other combination vaccine manufacturers face no new competitive pressure from Takeda in the polio vaccine segment. The competitive landscape remains dominated by established hexavalent and other combination formulations with proven safety and efficacy profiles. Takeda's vaccine portfolio focus has shifted toward dengue (QDENGA) and other high-growth therapeutic areas.

Future Catalysts: No future development milestones are anticipated for sIPV, as the program is terminated. Potential catalysts for polio vaccine innovation would emerge from epidemiological changes (e.g., wild poliovirus resurgence in currently polio-free regions) or technological breakthroughs enabling superior immunogenicity or manufacturing efficiency. Such developments would likely benefit established manufacturers with existing regulatory approvals and manufacturing infrastructure rather than new entrants.

Expected Milestones: No future milestones are expected for this terminated program. Takeda's vaccine development efforts are directed toward other indications and modalities, as evidenced by the approval and commercialization of QDENGA.

Quick answers

Concise, citable answers optimized for AI answer engines.

What is sIPV?
Sabin-based inactivated poliomyelitis vaccine candidate by Takeda, terminated January 2020.
Indication?
Poliomyelitis prevention.
Sponsor?
Takeda.
Development phase?
Phase 2; program terminated.
Current status?
Terminated as of 31 January 2020.
Modality?
Inactivated viral vaccine (biological).
Mechanism of action?
Not disclosed; presumed immune response induction against poliovirus antigens.
Route of administration?
Not disclosed; presumed intramuscular injection.
Target?
Poliovirus (serotype coverage not specified).
Partner?
No partner identified.
FDA approved?
No; program terminated prior to approval.
EMA approved?
No; program terminated prior to approval.
Clinical trial?
NCT03092791 associated with Phase 2 development.
Main competitor?
INFANRIX HEXA (GlaxoSmithKline, EMA-approved hexavalent vaccine).
Other competitors?
HEXYON, conventional IPV, OPV formulations.
Why terminated?
Rationale not disclosed; likely competitive and strategic factors.
Takeda vaccine focus?
QDENGA (dengue vaccine, approved); sIPV terminated.
Internal code?
IPV-102.
Latest milestone date?
31 January 2020 (termination).
Peak sales projection?
Not disclosed.
License type?
Not disclosed.
Lead investigator?
Not disclosed.
First disclosed date?
Not disclosed.
Expected next milestone?
None; program terminated.
Consensus position?
Not disclosed.
Sabin vs. wild-type?
sIPV based on Sabin strains, distinct from conventional wild-type IPV.
Global polio status?
Wild poliovirus nearly eliminated; endemic in limited regions; vaccine demand sustained.

Evidence & sources

Reviewed by NovaPharmaNews Intelligence Desk. Last reviewed .

  1. ClinicalTrials.gov NCT03092791 (clinicaltrials)
  2. diphtheria (d), tetanus (t), pertussis (acellular, component) (pa), hepatitis b (rdna) (hbv), poliomyelitis (inactivated) (ipv) and haemophilus influenzae type-b (hib) conjugate vaccine (adsorbed) EU status (ema)
  3. inactivated CN status (fda)
  4. vaccine CN status (fda)
  5. Source: phase (source_attribution)
  6. MONDO Disease Ontology (MONDO:0017373) (mondo)
  7. Orphanet — poliomyelitis (orphanet)
  8. NCT00001185 (clinicaltrials_gov)
  9. NCT00092469 (clinicaltrials_gov)
  10. NCT00133445 (clinicaltrials_gov)
  11. NCT00137696 (clinicaltrials_gov)
  12. NCT00138268 (clinicaltrials_gov)
  13. AACT (ClinicalTrials.gov aggregate) (aact)
  14. ClinicalTrials.gov (clinicaltrials_gov)
  15. Open Targets Platform (opentargets)

Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.