Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication CLARINEX is a histamine-1 (H1) receptor antagonist indicated for: Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 2 years of age and older. ( 1.1 ) Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 6 months of age and older. FDA label
Also known as Desloratadine (Clarinex), SCH 034117, Clarinex
Desloratadine · 12 trials · 14 indications
The TNSS was used to evaluate participant nasal symptoms of: sneezing (daily frequency of attacks scored from 0 \[\<1 time or "none"\] to 4 \[≥21 times\]), rhinorrhea (daily frequency of blowing nose scored from 0 \[\<1 time or "none"\] to 4 \[≥21 times\]), nasal congestion (scored from 0 \[no nasal blockage\] to 4 \[completely obstructed all day\]), and nasal itching (scored from 0 \[none\] to 4 \[nose is itchy, requiring frequent rubbing or blowing nose) as rated in the participant's diary. The TNSS was the sum of the 4 nasal symptom sub-scores. TNSS scores ranged from 0 to 16, with a higher score indicating more frequent/severe nasal symptoms. Baseline (BL) measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement was an average from Day 1 to Day 13 (2 week average). Change from BL = Post BL measurement - BL measurement.
An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE.
An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE.
The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The change from Baseline in the sum of the pruritus/itch and overall rash scores at the Week 2 clinic visit was calculated.
An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE.
An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE.
The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher sum score indicating greater severity. The change from Baseline in the sum of the daytime and nighttime pruritus/itch scores at Week 2 clinic visit was calculated.
An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug is also an AE.
An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug is also an AE.
The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms.
An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who experienced an AE, regardless of causality or severity, was summarized.
An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who discontinued study drug, whether permanently or temporarily, due to an AE was summarized.
| Arm | Type | Description |
|---|---|---|
| Desloratadine | EXPERIMENTAL | After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) orally (PO) once daily (QD) in the morning for 2 weeks during the Treatment Period. |
| Placebo | PLACEBO_COMPARATOR | After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period. |
| Desloratadine 5 mg | EXPERIMENTAL | Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks |
| Desloratadine 10 mg | EXPERIMENTAL | Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks |
| Desloratadine: Eczema/Dermatitis | EXPERIMENTAL | Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient antipruritic efficacy and there is no safety concern. |
| Desloratadine: Dermal Puritus | EXPERIMENTAL | Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern. |
| Desloratadine and Cetirizine Crossover | EXPERIMENTAL | To compare the preference in taste between desloratadine and cetirizine. |
| desloratadine followed by levocetirizine | EXPERIMENTAL | Subjects in this arm received desloratadine 5 mg daily for 8 days, followed by 10 day washout period, then followed by levocetirizine 5 mg daily for 8 days |
| levocetirizine followed by desloratadine | EXPERIMENTAL | Subjects in this arm received levocetirizine 5 mg daily for 8 days, followed by 10 day washout period, then followed by desloratadine 5 mg daily for 8 days |
| Arm 1 | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| DL | EXPERIMENTAL | Desloratadine syrup once daily |
| DL 2.5 mg | ACTIVE_COMPARATOR | Desloratadine 2.5 mg twice daily (BID) + Placebo for Oxybutynin 2.5 mg BID for 7 days |
| OXY 5 mg | ACTIVE_COMPARATOR | Placebo for Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days |
| DL 2.5 mg + OXY 2.5 mg | EXPERIMENTAL | Desloratadine 2.5 mg BID + Oxybutynin 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days |
| DL 2.5 mg + OXY 5 mg | EXPERIMENTAL | Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days |
| Name | Type | Description |
|---|---|---|
| Desloratadine 5 mg | DRUG | Desloratadine 5 mg tablets |
| Placebo | DRUG | Placebo tablets |
| Desloratadine | DRUG | Desloratadine 5 mg tablets, given orally, once daily in the evening for 2 weeks |
| Desloratadine (Clarinex) | DRUG | Each subject received 5 mL of desloratadine syrup one time |
| Cetirizine (Zyrtec) | DRUG | Each subject received 5 mL of cetirizine syrup |
| levocetirizine | DRUG | levocetirizine 5 mg daily x 8 days |
| Desloratadine 2.5 mg | DRUG | Desloratadine 2.5 mg BID |
| Oxybutynin 2.5 mg | DRUG | Oxybutynin 2.5 mg BID |
| Placebo for Desloratadine 2.5 mg | DRUG | Placebo BID |
| Placebo for Oxybutynin 2.5 mg | DRUG | Placebo BID |
Inclusion Criteria: * Has at least a 2-year history of seasonal allergic rhinitis with typical symptoms * Male or female who is unlikely to conceive: a surgically sterilized female, female who has reached natural menopause, or is of reproductive potential and agrees to either remain abstinent or us...
Top 1 of 3 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150 |
Desloratadine is used to treat allergic conditions including allergic rhinitis, chronic idiopathic urticaria, atopic dermatitis, eczema, perennial allergic rhinitis, and post-nasal drip. It is a small molecule antihistamine developed by Organon & Co. for respiratory and allergic indications.
Desloratadine works as an antagonist at the HRH1 receptor, also known as the histamine H1 receptor. By blocking this target, it prevents histamine from triggering allergic symptoms such as sneezing, itching, and runny nose.
Desloratadine is developed by Organon & Co., which trades under the ticker OGN. Organon is the company responsible for the clinical development of this small molecule antihistamine.
Desloratadine is in Phase 3 clinical development. It has completed three Phase 3 trials and is investigational, meaning it is still being studied in clinical trials and has not been approved by the FDA for the indications listed.
Desloratadine has been studied in completed Phase 3 trials including NCT02320396 in seasonal allergic rhinitis, NCT01918033 in perennial allergic rhinitis, NCT01916980 in eczema and dermatitis, and NCT01916967 in chronic urticaria. All trials are completed and no active trials are ongoing.
Yes, Desloratadine is also known as Clarinex. Other names include Desloratadine 2.5 mg and Desloratadine 5 mg, which refer to different dosage strengths of the same medication.