Product Description
Sonelokimab (also known as M1095) is a novel trivalent nanobody comprised of monovalent camelid-derived (ie, from the Camelidae family of mammals, such as camels, llamas, and alpacas) nanobodies specific to human interleukin (IL)-17A, IL-17F, and human serum albumin. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/33894834/)
Mechanisms of Action: IL17A Inhibitor, IL17F Inhibitor
Novel Mechanism: Yes
Modality: Bispecific Antibody
Route of Administration: Subcutaneous
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Company: Merck KGaA
Company Location:
Company Founding Year: 1668
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Austria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Spain, United Kingdom, United States
Active Clinical Trial Count: 19
Recent & Upcoming Milestones
- Clinical Outcomes Expected - MoonLake Immunotherapeutics announced they will present P2 Arthritis, Psoriatic|Axial Spondyloarthritis results in 1Q27 for Sonelokimab
- Clinical Outcomes Expected - MoonLake Immunotherapeutics announced they will present P3 Arthritis, Psoriatic results in 1Q27 for Sonelokimab
- Clinical Outcomes Expected - MoonLake Immunotherapeutics announced they will present P3 Arthritis, Psoriatic results in 2Q27 for Sonelokimab
Highest Development Phases
Phase 3: Arthritis, Psoriatic|Hidradenitis Suppurativa|Skin Diseases, Bacterial|Suppuration|Sweat Gland Diseases
Phase 2: Axial Spondyloarthritis|Palmoplantar Pustulosis
Phase 1: Healthy Volunteers
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06768671 |
VELA-TEEN | P3 |
Active, not recruiting |
Sweat Gland Diseases|Suppuration|Skin Diseases, Bacterial|Hidradenitis Suppurativa |
2026-09-28 |
3% |
2026-05-07 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2024-513305-32-00 |
M1095-PPP-201 | P2 |
Recruiting |
Palmoplantar Pustulosis |
2026-02-28 |
2025-05-02 |
Treatments |
|
2024-513498-36-00 |
M1095-axSpA-202 | P2 |
Recruiting |
Axial Spondyloarthritis |
2026-05-05 |
2025-05-02 |
Treatments |
|
NCT06641089 |
IZAR-2 | P3 |
Active, not recruiting |
Arthritis, Psoriatic |
2027-01-04 |
63% |
2026-10-13 |
|
NCT07007637 |
M1095-HS-303 | P3 |
Enrolling by invitation |
Hidradenitis Suppurativa|Suppuration|Sweat Gland Diseases|Skin Diseases, Bacterial |
2028-06-13 |
5% |
2026-05-07 |
Primary Endpoints|Treatments |
2025-520564-17-00 |
M1095-HS-303 | P3 |
Not yet recruiting |
Hidradenitis Suppurativa |
2028-06-13 |
|||
NCT07223138 |
M1095-PSA-303 | P3 |
Enrolling by invitation |
Arthritis, Psoriatic |
2028-02-04 |
5% |
2025-12-20 |
Primary Endpoints|Start Date |
2025-522471-28-00 |
M1095-PSA-303 | P3 |
Not yet recruiting |
Arthritis, Psoriatic |
2028-02-04 |
|||
2024-516213-20-00 |
M1095-PSA-301 | P3 |
Recruiting |
Arthritis, Psoriatic |
2026-12-19 |
2025-05-02 |
Treatments |
|
2024-516219-25-00 |
M1095-PSA-302 | P3 |
Recruiting |
Arthritis, Psoriatic |
2026-12-19 |
2025-05-02 |
Treatments |
|
NCT06641076 |
IZAR-1 | P3 |
Active, not recruiting |
Arthritis, Psoriatic |
2026-05-28 |
37% |
2026-10-13 |
|
2024-511360-87-00 |
M1095-HS-301 | P3 |
Recruiting |
Hidradenitis Suppurativa |
2026-04-30 |
2025-05-02 |
Treatments |
|
2024-511363-28-00 |
M1095-HS-302 | P3 |
Recruiting |
Hidradenitis Suppurativa |
2026-04-30 |
2025-05-02 |
Treatments |
|
NCT06411899 |
M1095-HS-301 | P3 |
Completed |
Suppuration|Skin Diseases, Bacterial|Hidradenitis Suppurativa|Sweat Gland Diseases |
2025-09-02 |
41% |
2026-06-10 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT06994936 |
M1095-HV-102 | P1 |
Completed |
Healthy Volunteers |
2025-11-01 |
51% |
2025-12-11 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT06411379 |
M1095-HS-302 | P3 |
Completed |
Sweat Gland Diseases|Suppuration|Skin Diseases, Bacterial|Hidradenitis Suppurativa |
2025-08-14 |
41% |
2026-06-10 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2024-514504-13-00 |
M1095-snSpA-202 | P2 |
Not yet recruiting |
Axial Spondyloarthritis|Arthritis, Psoriatic |
2026-02-08 |
2025-05-02 |
Treatments |
|
2021-005928-38 |
2021-005928-38 | P2 |
Active, not recruiting |
Hidradenitis Suppurativa |
2024-08-23 |
|||
2021-005947-58 |
2021-005947-58 | P2 |
Completed |
Arthritis, Psoriatic |
2024-01-10 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |