Drugs / Tafluprost
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ZIOPTAN | — | 2012-02-10 | fda.gov ↗ |
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02102750 | Jun 2014 → May 2017 | glaucoma, ocular hypertension | Santen Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03292796 | Dec 2016 → Oct 2019 | open-angle glaucoma | Julie Dawson | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04455126 | Apr → Dec 2018 | glaucoma | Alexandria University | Completed | No outcome recorded |
| Phase 37 trials · 3 met primary | ||||||
| Phase 3 | NCT03822559 | Jan 2019 → Apr 2023 | open-angle glaucoma | Santen Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT01254604 | Dec 2011 → May 2013 | ocular hypertension, open-angle glaucoma | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT01292460 | Feb 2011 → Sep 2012 | ocular hypertension, open-angle glaucoma | Santen Inc. | Completed | Met primary |
| Phase 3 | NCT01087671 | Apr → Oct 2010 | ocular hypertension, open-angle glaucoma | Santen Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01026831 | Jan → Sep 2010 | ocular hypertension, open-angle glaucoma | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00596791 | Jan → Jul 2008 | ocular hypertension, open-angle glaucoma | Santen Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00918346 | Sep 2005 → Mar 2006 | ocular hypertension, open-angle glaucoma | Santen Inc. | Completed | No outcome recorded |
| Phase 410 trials · 1 met primary | ||||||
| Phase 4 | NCT05299593 | Jun 2020 → Jun 2022 | ocular hypertension, open-angle glaucoma | Fondazione G.B. Bietti, IRCCS | Unknown | No outcome recorded |
| Phase 4 | NCT04654611 | Feb 2019 → Feb 2020 | ocular hypertension, open-angle glaucoma | Tun Hussein Onn National Eye Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03204487 | May 2016 → Apr 2017 | ocular hypertension, open-angle glaucoma | Ordination Dr. Hommer | Completed | No outcome recorded |
| Phase 4 | NCT02471105 | Sep 2015 → May 2017 | glaucoma, ocular hypertension | Universitaire Ziekenhuizen KU Leuven | Unknown | Met primary |
| Phase 4 | NCT01927406 | Jun 2014 → Dec 2016 | endocrine exophthalmos, glaucoma, ocular hypertension | Stanford University | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT01979913 | Oct 2013 → Apr 2014 | ocular hypertension, open-angle glaucoma | Dr. Anton Hommer | Completed | No outcome recorded |
| Phase 4 | NCT03104621 | Mar 2013 → Sep 2014 | open-angle glaucoma | Gangnam Severance Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01162603 | Mar 2011 → Apr 2012 | ocular hypertension, open-angle glaucoma | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia | Completed | No outcome recorded |
| Phase 4 | NCT01369771 | Aug 2010 → Jun 2012 | ocular hypertension, open-angle glaucoma | FinnMedi Oy | Completed | No outcome recorded |
| Phase 4 | NCT00966940 | Sep 2009 → Mar 2010 | glaucoma | Alcon Research | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04737928 | Apr 2018 → Jan 2019 | open-angle glaucoma | Santen Pharmaceutical (Taiwan) Co., LTD | Completed | No outcome recorded |
| Comparator or background therapy7 trials | ||||||
| Phase 1 | NCT01434888 Comparator | Sep → Dec 2011 | — | Santen Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT01654484 Comparator | Jul → Nov 2012 | open-angle glaucoma | Santen Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01433900 Comparator | May 2012 → May 2013 | glaucoma | Paolo Fogagnolo | Unknown | No outcome recorded |
| Phase 3 | NCT01342081 Comparator | May 2011 → Sep 2012 | ocular hypertension, open-angle glaucoma | Santen Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT01306461 Comparator | Mar 2011 → Apr 2012 | ocular hypertension, open-angle glaucoma | Santen Inc. | Completed | No outcome recorded |
| Phase 4 | NCT02802137 Comparator | Mar → Dec 2015 | eye adnexa disorder, open-angle glaucoma | Aristotle University Of Thessaloniki | Completed | No outcome recorded |
| Phase 4 | NCT01263444 Background | Mar 2011 → Apr 2013 | glaucoma, ocular hypertension | Alcon Research | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-04-04 | Santen Gmbh | Regulatory Santen Announces China NMPA Approval of Tapcom🄬 in Patients with Open-Angle Glaucoma or Ocular Hypertension santen.com ↗ |
| 2023-02-08 | Santen Gmbh | Regulatory Santen Announces China NMPA Acceptance of STN1011101 Marketing Authorization Application in Patients with Open-Angle Glaucoma or Increased Intraocular Eye Pressure santen.com ↗
Santen Announces China NMPA Acceptance of STN1011101 Marketing Authorization Application in Patients with Open-Angle Glaucoma or Increased Intraocular Eye Pressure |
| 2012-02-13 | Merck Sharp & Dohme LLC | Regulatory FDA Approves ZIOPTAN™ (tafluprost ophthalmic solution), Merck’s Once-Daily, Preservative-Free Ophthalmic Medication merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved ZIOPTANTM (tafluprost ophthalmic solution) 0.0015%, the first preservative-free prostaglandin analog ophthalmic solution. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-04-04 | Santen Gmbh | Santen Announces China NMPA Approval of Tapcom🄬 in Patients with Open-Angle Glaucoma or Ocular Hypertension santen.com ↗ |
| 2023-05-11 | Prasco LLC | Prasco Launches Authorized Generic of ZIOPTAN® Ophthalmic Solution prasco.com ↗ |
| 2023-02-08 | Santen Gmbh | Santen Announces China NMPA Acceptance of STN1011101 Marketing Authorization Application in Patients with Open-Angle Glaucoma or Increased Intraocular Eye Pressure santen.com ↗ |
| 2012-02-13 | Merck Sharp & Dohme LLC | FDA Approves ZIOPTAN™ (tafluprost ophthalmic solution), Merck’s Once-Daily, Preservative-Free Ophthalmic Medication merck.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 31 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tafluprost | “prostaglandin analog eyedrop (bimatoprost 0.01%, travoprost z 0.004%, tafluprost 0.0015% or latanoprost 0.005%) will be administered once a day, topically, into one - randomised eye.” NCT01927406 ↗27“Preservative Free Tafluprost (Saflutan® Augentropfen)” NCT01979913 ↗ “Latanoprost Travaprost Bimatoprost Tafluprost” NCT03292796 ↗ “Tafluprost” NCT01263444 ↗ |
| Known as | AFP-168 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1963683 ↗ |
| Known as | MK-2452 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1963683 ↗ |
| Known as | Saflutan | “Tafluprost 15µg/ml (Saflutan® 15 microgram/ml Augentropfen im Einzeldosisbehältnis, Merck Sharp \& Dohme, Wien)” NCT03204487 ↗1“Preservative Free Tafluprost (Saflutan® Augentropfen)” NCT01979913 ↗ |
| Known as | TAF | “Furthermore, a total of 375 prior prostaglandin analog (PGA) users were randomized within the prostaglandin stratum (PS) to receive either FC (n = 188) or tafluprost 0.0015%...” PMID 25447269 ↗ Dec 2014 |
| Known as | Taflotan | “Tafluprost (trade names Taflotan or Taflotan-S by Santen Pharmaceutical) is a prostaglandin analogue.” NCT03104621 ↗ |
| Known as | Taflotan-S | “Tafluprost (trade names Taflotan or Taflotan-S by Santen Pharmaceutical) is a prostaglandin analogue.” NCT03104621 ↗ |
| Known as | Zioptan | ChEMBL registry synonym — accepted as the source's own label CHEMBL1963683 ↗ |
| Action | Activate | “Prostanoid FP receptor agonist” CHEMBL1963683 ↗ |
| Modality | Other / unclassified | “tafluprost, a preservative-free (PF) prostaglandin analogue” PMID 22310086 ↗ Feb 2012 |
| Route | Topical | “topical administration” NCT00966940 ↗ |
| Target | PTGFR | “Prostanoid FP receptor agonist” CHEMBL1963683 ↗ |