The development pipeline
Merging global experience and technology to offer patients a brighter future
To promote our network-based drug discovery and global R&D efforts, Santen is placing significant emphasis on strengthening our relationships with universities, research organisations and other pharmaceutical firms to conceive new treatments for patients around the world. We hope such relationships will lead to the discovery and launch of novel therapies for severe dry eye disease, glaucoma, diabetic macular oedema and uveitis, a condition with limited treatment options.
Pipeline of prescription pharmaceuticals (clinical stage) As of October 2022
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An ophthalmic emulsion which improves vernal keratoconjunctivitis by immunosuppressive effect. Cationic emulsion technology has enhanced ocular tissue penetration. Launched successively in European countries since October 2018. Launched successively in Asian countries after receiving approval for an indication extension for Ikervis in August 2019. Launched in November 2019 in Canada. Launched in May 2022 in the U.S. and obtained marketing approval in April 2022 in China.
A dry eye treatment which stimulates secretion of mucin and aqueous components from the corneal and conjunctival epithelium. Long-lasting drug. Received manufacturing and marketing approval in June 2022 in Japan.
An ophthalmic suspension which treats Fuch’s endothelial corneal dystrophy via mTOR inhibition. Phase 1 has completed, and the IND for Phase 2a in US and other countries has been submitted to US FDA (*The development code (STN1010904) is due to be assigned to the product when Santen obtains exclusive license upon completion of Phase 2 clinical trial.)
An ophthalmic suspension which improves meibomian gland function via mTOR inhibition. Completed Phase 2a in August 2022 in Japan.
A fixed dose combination drug of a prostaglandin F2α derivative and a beta-adrenergic receptor blocker. Launched in Japan in November 2014. Launched successively in European countries since January 2015. Launched successively in Asian countries since April 2016. Conducting Phase 3 from January 2019 in China.
• Ocular hypertension
A histamine H₁ receptor antagonist with mediator release inhibitor function, as treatment for allergic conjunctivitis. Ophthalmic cream. Completed Phase 3 in October 2022 in Japan.
An EP2 receptor agonist with a new mechanism of action. Launched in November 2018 in Japan. Launched successively in Asian countries since launch in February 2021 in Korea. Received marketing approval in September 2022 in the U.S.
• Ocular hypertension
A prostaglandin analogue eye drop drug product with a novel mode of action that is a dual agonist for both FP and EP3 receptors for the treatment of glaucoma and ocular hypertension. Started Phase 2 (exploratory study) in September 2021 in Europe. Completed an additional Phase 2 in December 2021 in the U.S. Started Phase 3 in August 2022 in Japan.
• Ocular hypertension
Non-selective muscarinic antagonist which reduces juvenile myopia progression. Conducting Phase 2/3 from August 2019 in Japan.Completed Phase 1 in April 2022 in China. Completed P2 in April 2020 in Asia.
Non-selective muscarinic antagonist which reduces juvenile myopia progression. Sydnexis Inc., the licensor, is conducting Phase 3 trial in Europe and the U.S. Santen has obtained the exclusive license for Europe, Middle East and Africa.
A drainage implant device designed to lower and sustain intraocular pressure (IOP) for the treatment of primary open-angle glaucoma through the drainage of aqueous humor. Launched (soft launch) in July 2022 in Japan. Launched in Europe in April 2019. Filed successively for marketing approval in Asian countries since March 2020 and received approval in Singapore and other countries since September 2021.
License-out to Glaukos in Americas, Australia and New Zealand in May 2021. Received a not approvable letter of PMA from FDA in April 2022 in U.S. Received marketing approval in March 2021 in Canada and in May 2021 in Australia.
An ophthalmic emulsion of a prostaglandin F2α derivative, for the treatment of glaucoma and ocular hypertension. Completed Phase 3 in March 2022 in Europe and Asia. Filed for marketing approval in September 2022 in Europe.
• Ocular hypertension
Selective muscarinic M2 antagonist which reduces juvenile myopia progression. Reduce mydriasis to selectively inhibit a subtype of receptors. Completed Phase1 in September 2021 in Japan.
Improvement of presbyopia by improving lens elasticity. Completed Phase 1 in April 2022 in Japan.
A direct-acting alpha adrenergic receptor agonist. Developed and sold by RVL Pharmaceuticals in the U.S. Started Phase 3 in October 2022 in Japan
A ROCK (Rho-associated kinase) inhibitor. Developed and sold by Aerie in the U.S. Conducting Phase 3 from November 2020 in Japan. Filed for marketing approval in March 2022 in Asia.
• Ocular hypertension
A fixed dose combination drug of a ROCK (Rho-associated kinase) inhibitor and a prostaglandin F2α derivative. Developed and sold by Aerie in the U.S. Received marketing approval in Europe. Filed for marketing approval in May 2022 in Asia.
• Ocular hypertension
Changes from Q1 FY2022 (August 4, 2022)
Santen discloses the information on the ongoing clinical studies to confirm safety and efficacy of our drugs on the websites as below.
| Dev. code | Changes |
| STN1011700 / DE-117 | Received marketing approval in September 2022 in the U.S. |
| STN1012600 / DE-126 | Started Phase 3 in August 2022 in Japan. |
| STN1013001 / DE-130A | Filed for marketing approval in September 2022 in Europe. |
| STN1013800 | Started Phase 3 in October 2022 in Japan. |
