Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Acne mRNA (messenger ribonucleic acid) vaccine
Acne mRNA vaccine · 3 trials · 1 indication
Presence of unsolicited systemic adverse events (AEs) reported
Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant diary \[PDi\] and in the case report form \[CRF\])
Presence of unsolicited adverse events (AEs) reported
Presence of SAEs (Serious Adverse Events), MAAEs (Medically Attended Adverse Event), AESIs (Adverse Event of Special Interest) and AEs (Adverse Events) leading to study discontinuation
pre-listed in the participant diary \[PDi\] and in the case report form \[CRF\]
Presence of all SAEs
Presence of out-of-range biological test results (including shift from baseline values)
Presence of all SAEs and AESIs
Presence of unsolicited systemic adverse events (AEs) reported
Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant diary \[PDi\] and in the case report form \[CRF\])
Presence of medically attended adverse events (MAAEs)
Presence of all serious adverse events (SAEs)
Presence of AEs of special interest (AESIs)
Presence of all serious adverse events (SAEs) and adverse events of special interest (AESIs)
| Arm | Type | Description |
|---|---|---|
| Dose 1 sub-cohort - Group 1 | EXPERIMENTAL | 3 injections |
| Dose 1 sub-cohort - Group 2 | PLACEBO_COMPARATOR | 3 injections |
| Dose 2 sub-cohort - Group 3 | EXPERIMENTAL | 3 injections |
| Dose 2 sub-cohort - Group 4 | PLACEBO_COMPARATOR | 3 injections |
| Dose 3 sub-cohort - Group 5 | EXPERIMENTAL | 3 injections |
| Dose 3 sub-cohort - Group 6 | PLACEBO_COMPARATOR | 3 injections |
| Dose 1 main cohort - Group 7 | EXPERIMENTAL | 3 injections |
| Dose 2 main cohort - Group 8 | EXPERIMENTAL | 3 injections |
| Dose 3 main cohort - Group 9 | EXPERIMENTAL | 3 injections |
| Main cohort - Group 10 | PLACEBO_COMPARATOR | 3 injections |
| Sentinel Cohort Arm 1 | EXPERIMENTAL | Participants will receive 2 Acne mRNA Vaccine injections |
| Sentinel Cohort Arm 2 | PLACEBO_COMPARATOR | Participants will receive 2 Placebo injections |
| Main Cohort Arm 1 | EXPERIMENTAL | Participants will receive 2 Acne mRNA Vaccine injections |
| Main Cohort Arm 2 | PLACEBO_COMPARATOR | Participants will receive 2 Placebo injections |
| Sentinel Cohort A - Experimental | EXPERIMENTAL | Two administrations of the Acne mRNA vaccine will be injected in three increasing doses |
| Sentinel Cohort A - Placebo | PLACEBO_COMPARATOR | Two administrations of placebo will be injected |
| Sentinel Cohort B - Experimental | EXPERIMENTAL | Three administrations of the Acne mRNA vaccine will be injected in two increasing doses |
| Sentinel Cohort B - Placebo | PLACEBO_COMPARATOR | Three administrations of placebo will be injected |
| Main Cohort A - Experimental | EXPERIMENTAL | Two administrations of the Acne mRNA vaccine will be injected in three increasing doses |
| Main Cohort A - Placebo | PLACEBO_COMPARATOR | Two administrations of placebo will be injected |
| Main Cohort B - Experimental | EXPERIMENTAL | Three administrations of the Acne mRNA vaccine will be injected in two increasing doses |
| Main Cohort B - Placebo | PLACEBO_COMPARATOR | Three administrations of placebo will be injected |
| Name | Type | Description |
|---|---|---|
| Acne mRNA (messenger ribonucleic acid) vaccine | BIOLOGICAL | IM injection |
| Placebo | BIOLOGICAL | IM injection |
| Acne mRNA vaccine | BIOLOGICAL | Pharmaceutical form: suspension for injection Route of administration: intramuscular |
Inclusion Criteria: * Aged 12 to 17 years on the day of the first study intervention administration * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests as judged by the investigator * Clinical diagnosis of ...
Top 3 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 3 | PHASE1 | Acne mRNA vaccine |
| Hoth Therapeutics, Inc. | HOTH | 1 | PHASE2 | HT-001 |
| Sagimet Biosciences Inc. Class A | SGMT | 1 | PHASE1 | TVB-3567 |
The Acne mRNA vaccine is an investigational messenger ribonucleic acid (mRNA) vaccine being developed by Sanofi for the treatment of acne. It is designed as an immunotherapeutic approach to acne and is currently in clinical development, with Phase 2 status overall. It is not yet approved for any use.
The Acne mRNA vaccine is being studied for the treatment of acne, including mild, moderate, and severe forms. Clinical trials have enrolled adolescents and adults with acne. It is an investigational product and has not been approved for any indication.
The Acne mRNA vaccine is being developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical trials evaluating the vaccine in acne.
The Acne mRNA vaccine is in Phase 2 clinical development. Sanofi is running three trials in total, all currently active, with a combined planned enrollment of 1,438 participants. The vaccine remains investigational and has not been approved by the FDA.
Three trials are evaluating the Acne mRNA vaccine: NCT07756957, a Phase 2 study in adolescents aged 12 to 17 with moderate to severe acne that is not yet recruiting; NCT07013747, a Phase 1 study in adults with mild acne that is recruiting in the United States; and NCT06316297, a Phase 1 study in adults with moderate to severe acne recruiting in the United States, Australia, Canada, and Puerto Rico.
Yes, the Acne mRNA vaccine and Acne mRNA (messenger ribonucleic acid) vaccine refer to the same investigational product from Sanofi. The longer name simply spells out mRNA as messenger ribonucleic acid. Both names describe the same vaccine candidate being studied in acne.