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Also known as Fexofenadine HCl New Formulation Tablet, Fexofenadine, fexofenadine HCL (M016455), Fexofenadine (loratadine if not available)
Fexofenadine New Formulation · 7 trials · 5 indications
TNSS-3=composite score calculated as sum of rhinorrhea, sneezing, and nasal itching scores (TNSS-3: scale of each symptom is scored from 0 to 3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. Individual scores were collected in e-diary. AUC of TNSS from time of the first observation to time of the last observation (AUC \[0-6 hr\]) was calculated by using the linear trapezoid method. Trapezoidal rule involves dividing the area into a number of strips of equal width. Then, approximating the area of each strip by the area of the trapezium formed when a chord replaces upper end. Sum of these approximations gives final numerical result of area under the curve. AUC range: Arm A=0.0-43.5; Arm B=2.1-39.9.
| Arm | Type | Description |
|---|---|---|
| Arm A (active-active) | EXPERIMENTAL | Two days of pre-treatment with Fexofenadine 180 mg each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4. |
| Arm B (placebo-active) | EXPERIMENTAL | Two days of pre-treatment with tablet of matching placebo each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4. |
| FEX 60 mg | ACTIVE_COMPARATOR | Study medications is administered one hour before or two hours after a meal twice a day. Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination) Double-blind treatment period: 1 tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg /pseudoephedrine 60 mg (fixe dose combination) |
| FEX 60 mg/PSE 60 mg | EXPERIMENTAL | Study medications is administered one hour before or two hours after a meal twice a day. Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination Double-blind treatment period: 1 tablet of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination) + 1 placebo tablet of fexofenadine 60 mg / pseudoephedrine 60 mg (fixe dose combination) |
| FEX 60 mg/PSE 120 mg | EXPERIMENTAL | Study medications is administered one hour before or two hours after a meal twice a day. Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination) Double-blind treatment period: 2 tablets of fexofenadine 30 mg/pseudoephedrine 60 mg (fixe dose combination) + 1 placebo tablet of fexofenadine 30 mg |
| Age 6 months - 2 years | EXPERIMENTAL | Patients between 6 months and 2 years old - Type: Experimental |
| Age 2 - 11 years | EXPERIMENTAL | Patients between 2 and 11 years (and under 10.5 kg) |
| Age 2 - 11 years (and over 10.5 kg) | EXPERIMENTAL | Patients between 2 and 11 years (and over 10.5 kg) |
| Name | Type | Description |
|---|---|---|
| Fexofenadine | DRUG | Fexofenadine oral tablet |
| Placebo | DRUG | Fexofenadine matching placebo oral tablet |
| fexofenadine HCL (M016455) | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| pseudoephedrine | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| fexofenadine HCL matching placebo | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| pseudoephedrine matching placebo | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| Fexofenadine, Comparator = Montelukast | DRUG | - |
| fexofenadine/Allegra (M016455) | DRUG | Pharmaceutical form:dry syrup formulation to be suspended in water Route of administration: oral |
Inclusion Criteria: * Participants are eligible to be included in the study only if all of the following criteria apply: * Participant is willing to provide written informed consent. * Adult participants (18 to 80 years old) suffering from seasonal allergic rhinitis (SAR) provoked by Ragweed pollen...
Top 16 of 18 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 27 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | tilrekimig and rHuPH20, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
Fexofenadine New Formulation is an investigational small molecule developed by Sanofi (ticker SNY) for respiratory and allergic conditions. It is being studied in asthma, atopic dermatitis, perennial rhinitis, and seasonal allergic rhinitis. The program is in Phase 3 development, with completed randomized, double-blind trials enrolling about 3,200 participants in total.
Fexofenadine New Formulation is being studied for asthma, atopic dermatitis, perennial rhinitis, seasonal rhinitis, and seasonal allergic rhinitis. These are the conditions listed across its clinical program. It remains investigational for these uses and is not described as approved for them.
Fexofenadine New Formulation targets HRH1, the histamine H1 receptor, and acts as an antagonist at that receptor. Blocking HRH1 is the mechanism studied across its allergy and respiratory indications. The asset is a small molecule in Sanofi's respiratory pipeline.
Sanofi, which trades under the ticker SNY, is the developer of Fexofenadine New Formulation. Sanofi is listed as the sponsor of the clinical program covering asthma, atopic dermatitis, and rhinitis indications.
Fexofenadine New Formulation is in Phase 3 development. Three trials are recorded as completed and none are currently active. The program includes Phase 3 work in seasonal allergic rhinitis and Phase 2 studies in pediatric atopic dermatitis and perennial allergic rhinitis.
Completed trials include NCT05692154, a Phase 3 placebo-controlled study of 2-day pre-treatment in seasonal allergic rhinitis in Canada, and NCT01306721, a Phase 3 study in seasonal rhinitis in Japan. Pediatric Phase 2 studies NCT01244230 in atopic dermatitis and NCT01244217 in perennial allergic rhinitis also completed in Japan.
Fexofenadine New Formulation is also known as fexofenadine HCl new formulation tablet and appears in trial records under fexofenadine/Allegra and fexofenadine HCL (M016455). Fexofenadine is the active ingredient associated with the Allegra name, so searches for these terms refer to the same fexofenadine program.