nerandomilast
Small moleculeapprovedOrphan Drug FDA
Approved
Oct 7, 2025
Clinical trial activity
31 trials · 3 clinical orgs · 1 marketing orgs
Phase 1
23
Phase 2
8
Phase 3
5
Phase 4
0
Earliest trial started May 1, 2012 (NCT01594515)
Timeline
2010s
- Jan 1, 2012
Boehringer Ingelheim — Earliest Phase 1 Sponsor(trial)
2020s
- Jan 1, 2020
Boehringer Ingelheim — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2022
Boehringer Ingelheim — Earliest Phase 3 Sponsor(trial)
- Aug 15, 2022
Orphan Drug Designation
- Oct 7, 2025
Earliest FDA Approval
- Oct 7, 2025
Boehringer Ingelheim — Marketing Organization
Indications
Approved for
Mechanism of action
- Phosphodiesterase 4BINHIBITOR
PDE4B inhibitor
Approval history
- approvedPriority reviewOct 7, 2025
Chemistry & pharmacology
Loading structure…
SMILES
[O-][S+]1CCc2nc(N3CCC(c4ncc(Cl)cn4)CC3)nc(NC3(CO)CCC3)c21- Mol. weight
- 448.98 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL5314532 ↗
Also known as
- bi1015550
- bi 1015550
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07201922 | Phase 3 | Jan 23, 2026 | Boehringer Ingelheim |
| NCT06806592 | Phase 3 | Sep 13, 2025 | Boehringer Ingelheim |
| NCT07081932 | Phase 1 | Aug 26, 2025 | Boehringer Ingelheim |
| NCT07100964 | Phase 1 | Aug 11, 2025 | Boehringer Ingelheim |
| NCT06241560 | Phase 2 | Nov 8, 2024 | Boehringer Ingelheim |
| NCT06624072 | Phase 1 | Oct 11, 2024 | Boehringer Ingelheim |
| NCT06238622 | Phase 3 | Jul 10, 2024 | Boehringer Ingelheim |
| NCT06408870 | Phase 1 | Jun 6, 2024 | Boehringer Ingelheim |
| NCT06415045 | Phase 1 | May 28, 2024 | Boehringer Ingelheim |
| NCT06393127 | Phase 1 | May 23, 2024 | Boehringer Ingelheim |
| NCT06195072 | Phase 2 | Apr 15, 2024 | Boehringer Ingelheim, Sanofi, Scleroderma Research Foundation, Inc. |
| NCT06107036 | Phase 1 | Feb 26, 2024 | Boehringer Ingelheim |
| NCT06139302 | Phase 1 | Dec 20, 2023 | Boehringer Ingelheim |
| NCT06070610 | Phase 1 | Nov 8, 2023 | Boehringer Ingelheim |
| NCT05707403 | Phase 1 | Feb 14, 2023 | Boehringer Ingelheim |
| NCT05718648 | Phase 1 | Feb 9, 2023 | Boehringer Ingelheim |
| NCT05661344 | Phase 1 | Jan 18, 2023 | Boehringer Ingelheim |
| NCT05633862 | Phase 1 | Jan 13, 2023 | Boehringer Ingelheim |
| NCT05550636 | Phase 1 | Oct 11, 2022 | Boehringer Ingelheim |
| NCT05321082 | Phase 3 | Oct 5, 2022 | Boehringer Ingelheim |
Showing 20 of 31 trials
Page 1 / 2
Organizations
Research & Development (3)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Boehringer Ingelheim | For profit | 31 | 30 | 3 | 2012 |
| Sanofi | For profit | 1 | 0 | 1 | 2024 |
| Scleroderma Research Foundation, Inc. | Academic/Hospital | 1 | 1 | 1 | 2024 |
3 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Boehringer Ingelheim | For profit | MKTG | Oct 7, 2025 |