Drugs / lotilaner
lotilaner
also known as
TP-05 · TP-03 · XDEMVY · Adtab (previously lotilaner elanco) · Credelio · Lotilaner (ema epar: veterinary) · Lotimax
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed squamous blepharitis 1 milestone | |||||
| Filed | China (NMPA) | — | squamous blepharitis | 2024-12-17 | “用于治疗蠕形螨睑缘炎的全球创新眼科药物GPN01768（TP-03，洛替拉纳滴眼液，0.25%）已于2024年12月向国家药监局递交了新药上市申请并获得了受理” grandpharm.com ↗ “用于治疗蠕形螨睑缘炎的全球创新眼科药物GPN01768 (TP-03，洛替拉纳滴眼液，0.25%)正式向国家药监局递交了新药上市申请(NDA)并获得了受理” grandpharm.com ↗ “用于治疗蠕形螨睑缘炎的全球创新眼科药物GPN01768（TP-03，洛替拉纳滴眼液，0.25%）已于2024年12月向药监局递交了新药上市申请并获得了受理” grandpharm.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | XDEMVY | — | 2023-07-24 | fda.gov ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05720364 | Jan → May 2023 | — | Tarsus Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05138796 | May 2021 → Mar 2022 | — | Tarsus Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05138861 | Feb → Sep 2021 | — | Tarsus Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07443202 | Dec 2025 → Dec 2026 expected | rosacea conjunctivitis | Tarsus Pharmaceuticals, Inc. | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT05838170 | Mar → Nov 2023 | rosacea | Tarsus Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT05454956 | Aug 2022 → May 2023 | parasitic eyelid infestation | Tarsus Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05629390 | Oct 2022 → Sep 2023 | blepharitis | LianBio LLC | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07561450 | Apr → Aug 2026 overdue | parasitic eyelid infestation | Boston Sight | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06182358 | Dec 2023 → Jan 2025 | parasitic eyelid infestation | Tarsus Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT07562087 Comparator | Mar 2026 → Oct 2027 expected | Lyme disease | Tarsus Pharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-03-23 | Tarsus Pharmaceuticals, Inc. | Regulatory TP-03 (lotilaner ophthalmic solution) 0.25% Now Approved in China for the Treatment of Demodex Blepharitis, Triggering a $15M Milestone Payment to Tarsus tarsusrx.com ↗ |
| 2026-03-22 | GrandPharma (China) Co., Ltd. | Regulatory 全球创新的治疗蠕形螨睑缘炎产品TP-03在中国获批上市 grandpharm.com ↗
近日，远大医药(0512.HK)引进的用于治疗蠕形螨睑缘炎的全球创新眼科药物GPN01768 [TP-03, (洛替拉纳滴眼液) 0.25%]近日正式获得国家药监局颁发的药品注册证书，且在药品审评过程中未收到补充资料通知，实现“零发补”获批上市。 |
| 2025-05-25 | GrandPharma (China) Co., Ltd. | Regulatory 远大医药全球创新的治疗蠕形螨睑缘炎产品GPN01768在中国澳门获批上市 grandpharm.com ↗
近日，远大医药(0512.HK)用于治疗蠕形螨睑缘炎的全球创新眼科药物GPN01768 (TP-03，洛替拉纳滴眼液，0.25%)在中国澳门正式获批上市，这是本集团在眼科治疗创新领域的又一项重要进展，不仅为该产品未来在粤港澳大湾区的获批奠定了基础，也有望进一步促进其在中国大陆的落地。 |
| 2024-12-17 | GrandPharma (China) Co., Ltd. | Regulatory 远大医药全球创新的治疗蠕形螨睑缘炎产品上市许可申请获国家药监局受理 grandpharm.com ↗
近日，远大医药(0512.HK)用于治疗蠕形螨睑缘炎的全球创新眼科药物GPN01768 (TP-03，洛替拉纳滴眼液，0.25%)正式向国家药监局递交了新药上市申请(NDA)并获得了受理，这是本集团在眼科治疗创新领域的又一项重要进展。 |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-03-31 | Tarsus Pharmaceuticals, Inc. | Tarsus Doses First Participant in Calliope, A Phase 2 Clinical Trial of TP-05 (lotilaner), a Novel Investigational Oral Tablet for the Potential Prevention of Lyme Disease tarsusrx.com ↗ |
| 2026-03-23 | Tarsus Pharmaceuticals, Inc. | TP-03 (lotilaner ophthalmic solution) 0.25% Now Approved in China for the Treatment of Demodex Blepharitis, Triggering a $15M Milestone Payment to Tarsus tarsusrx.com ↗ |
| 2026-03-22 | GrandPharma (China) Co., Ltd. | 全球创新的治疗蠕形螨睑缘炎产品TP-03在中国获批上市 grandpharm.com ↗ |
| 2025-05-25 | GrandPharma (China) Co., Ltd. | 远大医药全球创新的治疗蠕形螨睑缘炎产品GPN01768在中国澳门获批上市 grandpharm.com ↗ |
| 2024-12-17 | GrandPharma (China) Co., Ltd. | 远大医药全球创新的治疗蠕形螨睑缘炎产品上市许可申请获国家药监局受理 grandpharm.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | lotilaner | “Xdemvy (lotilaner ophthalmic solution) 0.25%” NCT07561450 ↗9“TP-03, lotilaner ophthalmic solution, 0.25%” NCT05454956 ↗ |
| Known as | Adtab (previously lotilaner elanco) | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707310 ↗ |
| Known as | Credelio | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707310 ↗ |
| Known as | Lotilaner (ema epar: veterinary) | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707310 ↗ |
| Known as | Lotimax | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707310 ↗ |
| Known as | TP-03 | “TP-03 (Lotilaner Ophthalmic Solution), 0.25%” NCT05138861 ↗1“TP-03, lotilaner ophthalmic solution, 0.25%” NCT05454956 ↗ |
| Known as | TP-05 | “TP-05 (lotilaner oral), fasted group” NCT05720364 ↗ |
| Known as | XDEMVY | “XDEMVY (lotilaner ophthalmic solution) 0.25%, administered topically twice a day for approximately 43 days” NCT06182358 ↗1“Xdemvy (lotilaner ophthalmic solution) 0.25%” NCT07561450 ↗ |
| Action | Inhibit | “selectively inhibits parasite-specific gamma-aminobutyric acid (GABA)-gated chloride channels (GABA-Cls)” NCT05838170 ↗ |
| Modality | Small molecule | “a member of the isoxazoline family of compounds” NCT05838170 ↗ |
| Route | Oral | “TP-05 (lotilaner oral capsules)” NCT05138796 ↗ |