Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK1004723 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| GSK1004726 (1000mg) | ACTIVE_COMPARATOR | 1000mg aqueous suspension |
| Placebo | PLACEBO_COMPARATOR | Intranasal spray |
| GSK1004723 (200mg) | ACTIVE_COMPARATOR | 200 mg aqueous suspension |
| Subjects receiving GSK1004723 + placebo in cohort I and II | EXPERIMENTAL | Eligible subjects will receive GSK1004723 nasal spray with single doses of 50 micrograms, 100 micrograms, 200 micrograms, 500 micrograms and 1000 micrograms. Subjects will also receive placebo nasal spray. |
| Subjects receiving GSK1004723 200 micrograms in cohort III | EXPERIMENTAL | Eligible subjects will receive nasal spray of GSK1004723 with escalated repeat doses of 200 micrograms given once daily for 14 days. |
| Subjects receiving placebo in cohort III | EXPERIMENTAL | Eligible subjects will receive nasal spray of placebo given once daily for 14 days. |
| Subjects receiving GSK1004723 1000 micrograms in cohort IV | EXPERIMENTAL | Eligible subjects will receive nasal spray of GSK1004723 with escalated repeat doses of 1000 micrograms given once daily for 14 days. |
| Subjects receiving placebo in cohort IV | EXPERIMENTAL | Eligible subjects will receive nasal spray of placebo given once daily for 14 days. |
| Name | Type | Description |
|---|---|---|
| GSK1004723 (200mg) | DRUG | Intranasal antihistamine. |
| Placebo | OTHER | Equivalent to GSK1004723 in presentation etc. |
| GSK1004723 (1000mg) | DRUG | Intranasal antihistamine. |
| GSK1004723 | DRUG | GSK1004723 will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration. |
Inclusion Criteria: * Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma. * Male * Aged 18 - 65 * Weight 50kg+, BMI 19-32 kg/m2 * Exhibit response to Challenge Chamber and skin prick test. * Non-smoker * Capable of giving informed consent E...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150, Standard therapy for INCS |
| Polyrizon Ltd. | PLRZ | 1 | N/A | Undisclosed |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | - | Undisclosed |
GSK1004723 is an investigational small molecule being developed for allergic rhinitis, including seasonal allergic rhinitis. It is administered intranasally and is currently in Phase 2 clinical development. The drug is not approved and remains under study for the treatment of allergic rhinitis symptoms.
GSK1004723 is an intranasal H1/H3 dual antagonist, meaning it targets both histamine H1 and H3 receptors. By blocking these receptors, the drug is designed to modulate allergic responses in the nasal passages. This mechanism is being evaluated for its potential to treat allergic rhinitis.
GSK1004723 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for allergic rhinitis.
GSK1004723 is in Phase 2 clinical development. It has completed a Phase 1 first-in-human study and a Phase 2 allergen challenge chamber study. The drug is investigational and has not received regulatory approval for any use.
GSK1004723 has been studied in two completed clinical trials. NCT00694993 was a Phase 1 single and repeat dose first-in-human study in healthy male subjects. NCT00824356 was a Phase 2 allergen challenge chamber study comparing single dose intranasal GSK1004723 with placebo in male participants with allergic rhinitis.
GSK1004723 is the primary identifier for this investigational drug. No alternative names have been associated with it in clinical trial records. It is distinct from other allergy medications and is being studied specifically as an intranasal H1/H3 dual antagonist.