Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Lunsekimig
SAR443765 · 10 trials · 4 indications
Exposure-adjusted incidence rate is defined as the number of patients with at least one specific treatment emergent adverse event in question per 100 patients taking the treatment for 1 year.
The annualized moderate or severe COPD exacerbation rate up to 48 weeks treatment period compared to placebo
Eczema Area and Severity index is an Investigator-assessed validated tool used to measure the extent (area) and severity of atopic dermatitis (AD). Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
Asthma exacerbation event defined as: worsening of asthma requiring the use of systemic corticosteroids for ≥3 days; or hospitalization or emergency room visit due to asthma and requiring the use of systemic corticosteroids or death due to asthma
Exposure-adjusted incidence rate is defined as the number of patients with at least one specific treatment emergent adverse event in question per 100 patients taking the treatment for 1 year.
This score (NPS) is the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. NP is graded based on polyp size where: 0- no polyps and 4- large polyps causing complete obstruction of the inferior nasal cavity.
Incidence of adverse events (AEs) and treatment-emergent adverse events (TEAEs)
| Arm | Type | Description |
|---|---|---|
| Lunsekimig core study | EXPERIMENTAL | Subcutaneous (SC) administration of lunsekimig for up to 96 weeks, with the same inhaled controller medication as in the parent study (LABA + LAMA + ICS or LABA + LAMA) |
| Lunsekimig sub-study with ICS maintenance | EXPERIMENTAL | ICS withdrawal sub-study: SC administration of lunsekimig for up to 96 weeks, with the inhaled controller medication LABA + LAMA + ICS in the run-in period followed by randomization to maintain the same inhaled regimen |
| Lunsekimig sub-study with ICS withdrawal | EXPERIMENTAL | ICS withdrawal sub-study: SC administration of lunsekimig for up to 96 weeks, with the inhaled controller medication LABA + LAMA + ICS in the run-in period followed by randomization to withdraw ICS |
| Lunsekimig dose regimen A | EXPERIMENTAL | Participants will receive lunsekimig dose regimen A. |
| Lunsekimig dose regimen B | EXPERIMENTAL | Participants will receive lunsekimig dose regimen B. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive lunsekimig-matching placebo. |
| Lunsekimig | EXPERIMENTAL | Participant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) daily for 144 weeks |
| Lunsekimig arm A | EXPERIMENTAL | Participants will receive subcutaneous injection of lunsekimig dosing regimen A. |
| Placebo arm B | PLACEBO_COMPARATOR | Participants will receive subcutaneous injection of matching placebo. |
| Lunsekimig arm C | EXPERIMENTAL | Participants will receive subcutaneous injection of lunsekimig dosing regimen C. |
| Placebo arm D | PLACEBO_COMPARATOR | Participants will receive subcutaneous injection of matching placebo. |
| Lunsekimig arm E | EXPERIMENTAL | Participants will receive subcutaneous injection of lunsekimig dosing regimen E. |
| Placebo arm F | PLACEBO_COMPARATOR | Participants will receive subcutaneous injection of matching placebo. |
| Arm 1 | PLACEBO_COMPARATOR | Participant will receive placebo subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) for 24 weeks. |
| Arm 2 | EXPERIMENTAL | Participant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) for 24 weeks. |
| Lunsekimig Dose1 interval 1 | EXPERIMENTAL | Participants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 1 |
| Lunsekimig Dose 1 interval 2 | EXPERIMENTAL | Participants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 2 |
| Lunsekimig Dose 2 interval 1 | EXPERIMENTAL | Participants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 1 |
| Lunsekimig Dose 2 interval 2 | EXPERIMENTAL | Participants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 2 |
| SAR443765 | EXPERIMENTAL | Single dose administration of SAR443765 |
| Name | Type | Description |
|---|---|---|
| Lunsekimig | DRUG | * Pharmaceutical form: Solution for injection in prefilled syringe * Route of administration: Subcutaneous injection |
| Placebo | DRUG | Pharmaceutical form: solution for injection. Route of administration: Subcutaneous injection |
| Mometasone furoate nasal spray (MFNS) | DRUG | * Pharmaceutical form: Solution for administration via spray pump * Route of administration: intranasal spray |
| Short-Acting Beta Agonists (SABA) | DRUG | Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation |
| Fluticasone/Salmeterol | DRUG | Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration:Oral Inhalation |
| Budesonide/Formoterol | DRUG | Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation |
| Budesonide/Albuterol | DRUG | Pharmaceutical form: Aerosol for inhalation; Route of administration: Oral Inhalation |
| SAR443765 | DRUG | solution for injection |
| Salbutamol or levosalbutamol | DRUG | metered dose inhaler |
Inclusion Criteria: * Participants who completed the treatment period of EFC18243 or EFC18244 studies, including EOI visit * Contraception for male and female participants during the study intervention period and during 8 weeks following the last administration of study intervention. And: * Fema...
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 | 28 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | Tilrekimig, 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 |
SAR443765 is an investigational small molecule being developed for the treatment of asthma. It is currently in Phase 1 clinical development, meaning it has not yet been approved for any use. The drug is being studied in healthy participants and in asthmatic participants to evaluate its safety and tolerability.
SAR443765 is being developed by Sanofi, a multinational pharmaceutical company. Sanofi is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for asthma. The company is listed on the stock exchange under the ticker symbol SNY.
SAR443765 is in Phase 1 clinical development. This is the earliest stage of testing in humans, focused on assessing the drug's safety, tolerability, and pharmacokinetics. The drug is investigational and has not been approved by regulatory authorities for the treatment of asthma or any other condition.
SAR443765 has one completed Phase 1 clinical trial, identified by the National Clinical Trial number NCT05366764. This was a first-in-human study conducted in Germany and the United Kingdom, enrolling 36 participants, including healthy volunteers and asthmatic participants. The trial was randomized, double-blind, and placebo-controlled.
No, SAR443765 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug has not yet completed the clinical trials and regulatory review process required for approval. It is being studied for the treatment of asthma, but its safety and efficacy have not been established.