pharma · Asthma · Respiratory Syncytial Virus Infections
GlaxoSmithKline
GSK Glaxo Smith is a pharma organization headquartered in SAINT-AMAND LES EAUX, FR. Primary therapeutic focus areas include Asthma, Respiratory Syncytial Virus Infections, Hepatitis B, Chronic, Neoplasms, Influenza. Nova
Phase 1 · mab · Poliomyelitis
Poliorix (internal code 112581) is a monoclonal antibody therapeutic candidate developed by GlaxoSmithKline for the treatment of poliomyelitis. The program completed Phase 1 clinical evaluation, with the latest milestone recorded on 17 December 2018. While the precise mechanism of action remains undisclosed, the progra
Internal code 112581
Poliorix (internal code 112581) is a monoclonal antibody therapeutic candidate developed by GlaxoSmithKline for the treatment of poliomyelitis. The program completed Phase 1 clinical evaluation, with the latest milestone recorded on 17 December 2018. While the precise mechanism of action remains undisclosed, the program represents GSK's investigational approach to polio immunotherapy. The clinical development is supported by trial NCT00937404. GSK's strategy appears focused on advancing novel immunological interventions in infectious disease, though Poliorix itself has not progressed to later-stage development or regulatory approval based on available evidence. The program's current status is listed as completed Phase 1, with no disclosed information regarding advancement to Phase 2 or regulatory filing. Peak sales projections and consensus analyst positioning have not been publicly disclosed.
Poliomyelitis remains a significant global health concern despite decades of vaccination efforts, with endemic transmission persisting in limited geographic regions and ongoing risk of importation in non-endemic areas. The development of novel immunotherapeutic approaches, such as monoclonal antibodies, could address unmet needs in post-exposure prophylaxis, treatment of vaccine-derived poliovirus cases, or immunocompromised populations with inadequate vaccine responses. The competitive landscape for polio therapeutics is limited compared to preventive vaccines, creating potential market opportunity for novel treatments. Poliorix's positioning as a monoclonal antibody distinguishes it mechanistically from traditional inactivated poliovirus vaccines (IPV) and oral poliovirus vaccines (OPV), suggesting GSK's intent to explore therapeutic rather than purely preventive applications. The global polio eradication initiative and ongoing surveillance create sustained clinical and commercial relevance for innovative interventions. However, the program's completion of Phase 1 without disclosed advancement suggests either strategic deprioritization, development challenges, or transition to alternative formulations such as INFANRIX HEXA, GSK's approved hexavalent vaccine containing inactivated poliovirus component.
Drug Class: Monoclonal antibody (mAb) therapeutic
Modality: Monoclonal antibody
Indication: Poliomyelitis
Mechanism of Action: Not yet disclosed
Target: Not yet disclosed
Route of Administration: Not yet disclosed
Related Therapies: GSK manufactures INFANRIX HEXA, an approved hexavalent vaccine combining diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type-b conjugate vaccine. This approved product represents GSK's established polio immunization portfolio and may indicate the company's broader strategic focus on combination immunization rather than monoclonal antibody therapeutics for polio.
Patent Status: Not yet disclosed
First Approval: Not applicable; program remains in investigational stage with no regulatory approvals reported
Also known as: Polia, acute poliomyelitis, polio, infantile paralysis
Prevalence: Point prevalence: <1 / 1 000 000 (Europe) — source: Orphanet, not yet validated.
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.
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:
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).
Phase 1 trial initiated
Clinical trial NCT00937404 registered for Poliorix evaluation in poliomyelitis.
Phase 1 completion
Latest disclosed milestone recorded; Phase 1 development status marked as completed.
The competitive landscape for polio therapeutics is fragmented across vaccine and immunotherapy modalities. HEXYON (Sanofi Pasteur) and INFANRIX HEXA (GSK) represent approved hexavalent combination vaccines containing inactivated poliovirus component, dominating preventive immunization. TRITANRIX HEPB offers a pentavalent alternative. The competitor list provided includes vaccines targeting other infectious diseases (MRESVIA for RSV, COMIRNATY for COVID-19, QDENGA for dengue, M-M-RVAXPRO for measles/mumps/rubella, VAXCHORA for cholera, IXCHIQ for Rift Valley fever, and FOCETRIA for influenza), which are not direct polio therapeutics but reflect the broader vaccine market in which GSK competes. Poliorix's positioning as a monoclonal antibody represents a distinct therapeutic approach compared to traditional inactivated or live-attenuated vaccines. However, no approved monoclonal antibody therapeutics for poliomyelitis treatment are identified in the competitor set, suggesting either limited clinical validation of this approach or Poliorix's potential as a first-mover in this category. The absence of Phase 2 advancement or regulatory filings for Poliorix suggests the monoclonal antibody approach may face development or commercial challenges relative to established vaccine platforms.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| MRESVIA | Teva Pharma GmbH | Fusion glycoprotein F0 vaccine antigen | approved |
| COMIRNATY | Teva Pharma GmbH | Spike glycoprotein vaccine antigen | approved |
| QDENGA | Takeda | Biological vaccine - induces immune response | approved |
| MCOMBRIAX | Teva Pharma GmbH | — | approved |
| TRITANRIX HEPB | — | — | approved |
| M-M-RVAXPRO | — | — | approved |
| FLUCELVAX | — | — | approved |
| VAXCHORA | — | Biological vaccine - induces immune response | approved |
| IXCHIQ | — | Biological vaccine - induces immune response | approved |
| COVID-19 VACCINE (INACTIVATED, ADJUVANTED) VALNEVA | — | Biological vaccine - induces immune response | approved |
| FOCETRIA | — | — | approved |
| HEXYON | — | — | approved |
| NOREPINEPHRINE BITARTRATE | — | Adrenergic receptor agonist | Approved |
| MODAFINIL | — | Dopamine transporter inhibitor | Phase 3 |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
European Union (EMA): INFANRIX HEXA (containing inactivated poliovirus component) is approved by EMA under EMEA/H/C/000296, with Marketing Authorization Holder GlaxoSmithKline Biologicals S.A. and authorisation date of 12 February 2026 (note: this date appears to reflect a recent renewal or administrative update rather than initial approval). Poliorix itself has not received EMA approval.
China (NMPA): Poliorix is listed as in clinical trials status in China, with trial NCT00937404 registered on ClinicalTrials.gov.
United States (FDA): Regulatory status with FDA not yet disclosed.
Japan (PMDA): Regulatory status with PMDA not yet disclosed.
Overall Regulatory Status: Poliorix remains an investigational monoclonal antibody with no disclosed regulatory approvals, filings, or breakthrough designations. The program completed Phase 1 as of December 2018 with no public evidence of advancement to Phase 2 or regulatory submission.
Poliorix is an investigational monoclonal antibody therapeutic candidate developed by GlaxoSmithKline for the treatment of poliomyelitis. The specific mechanism of action and therapeutic indication (treatment vs. prevention) have not been publicly disclosed.
Poliorix is developed by GlaxoSmithKline (GSK). No partner or licensee has been disclosed.
Poliorix completed Phase 1 clinical evaluation as of 17 December 2018. No advancement to Phase 2 or later stages has been publicly disclosed, and the program status is listed as completed.
No, Poliorix has not received approval from the FDA, EMA, PMDA, or NMPA. The program remains in investigational stage with only Phase 1 completion disclosed.
Trial NCT00937404 is the registered clinical trial for Poliorix evaluation in poliomyelitis. Detailed trial design, participant numbers, and results have not been publicly disclosed.
The mechanism of action of Poliorix has not been disclosed. As a monoclonal antibody, it likely targets a specific antigen or immune pathway related to poliovirus, but the precise target and biological mechanism remain undisclosed.
The route of administration for Poliorix has not been disclosed.
No partner or licensing arrangement has been disclosed. GSK appears to be developing Poliorix independently.
The specific target of Poliorix monoclonal antibody has not been disclosed.
Poliorix is a monoclonal antibody therapeutic, distinct from traditional inactivated poliovirus vaccines (IPV) like those in INFANRIX HEXA or HEXYON. It represents a novel immunotherapeutic approach rather than a preventive vaccine, though its specific clinical positioning (treatment vs. prevention) has not been disclosed.
Peak sales projections for Poliorix have not been disclosed.
The first disclosure date for Poliorix has not been recorded in available data. The latest disclosed milestone is 17 December 2018, marking Phase 1 completion.
Analyst consensus positioning for Poliorix has not been disclosed.
The internal code for Poliorix is 112581.
No approved monoclonal antibody therapeutics for poliomyelitis treatment are identified in the available competitive set, suggesting Poliorix may represent a novel therapeutic approach if successfully developed.
While polio vaccines are highly effective for prevention, unmet needs may include post-exposure prophylaxis, treatment of vaccine-derived poliovirus cases, and enhanced immune response in immunocompromised populations—areas where a monoclonal antibody therapeutic could potentially provide benefit.
Poliorix → Drug → Target → Indication → Company → Trials → Competitors
Strategic Implications: GSK's development of Poliorix as a monoclonal antibody therapeutic represents a departure from the company's established vaccine-centric polio portfolio (INFANRIX HEXA). The completion of Phase 1 in December 2018 without subsequent public advancement to Phase 2 suggests either strategic deprioritization, unmet efficacy or safety criteria, or internal portfolio reallocation. The absence of disclosed partnership or licensing arrangements indicates GSK is pursuing this program independently.
Competitive Implications: No approved monoclonal antibody therapeutics for polio treatment are identified in the competitive set, suggesting either limited clinical validation of this modality or potential first-mover advantage if efficacy is demonstrated. However, the dominance of established vaccines (HEXYON, INFANRIX HEXA, TRITANRIX HEPB) in polio immunization creates a high barrier for novel therapeutics unless positioned for treatment rather than prevention or for immunocompromised populations.
Future Catalysts: Potential catalysts include Phase 2 trial initiation (not yet disclosed), regulatory interactions with FDA or EMA, or publication of Phase 1 data. The lack of disclosed next milestones or expected timelines limits visibility into program trajectory. GSK's continued focus on INFANRIX HEXA and broader vaccine portfolio may indicate reduced priority for Poliorix monoclonal antibody development.
Expected Milestones: No expected next milestones have been disclosed. The program's status as 'completed' Phase 1 with no advancement announcement suggests either dormancy or internal evaluation phase.
Concise, citable answers optimized for AI answer engines.
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.