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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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Ciclosporin DE-076C (STN1007603)

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.

Indication
Original/Licensor
Vernal keratoconjunctivitis
Original
 
P1
P2
P3
NDA filed
Approved
Launched
U.S.
May 2022
China
Apr 2022
Diquafosol sodium DE-089C (STN1008903)

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.

Indication
Original/Licensor
Dry eye
Merck Sharp & Dohme Corp. (U.S.)
 
P1
P2
P3
NDA filed
Approved
Launched
Japan
June 2022
Sirolimus (STN1010904)

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.)

Indication
Original/Licensor
Fuch's endothelial corneal dystrophy
Joint development with ActualEyes
 
P1
P2
P3
NDA filed
Approved
Launched
USA, France & India
Phase 2a
Sirolimus (STN1010905)

An ophthalmic suspension which improves meibomian gland function via mTOR inhibition. Completed Phase 2a in August 2022 in Japan.

Indication
Original/Licensor
Meibomian gland dysfunction
Original
 
P1
P2
P3
NDA filed
Approved
Launched
Japan
(Phase 2a)
Tafluprost/timolol maleate DE-111A (STN1011101)

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.

Indication
Original/Licensor
Glaucoma
• Ocular hypertension
Co-development with AGC
 
P1
P2
P3
NDA filed
Approved
Launched
China
Epinastine hydrochloride (STN1011402)

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.

Indication
Original/Licensor
Allergic conjunctivitis
Nippon Boehringer Ingelheim
 
P1
P2
P3
NDA filed
Approved
Launched
Japan
Omidenepag isopropyl DE-117 (STN1011700)

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.

Indication
Original/Licensor
Glaucoma
• Ocular hypertension
Co-development with Ube Industries
 
P1
P2
P3
NDA filed
Approved
Launched
U.S.
Sept 2022
Japan
Nov 2018
Asia
Feb 2021
Sepetaprost DE-126 (STN1012600)

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.

Indication
Original/Licensor
Glaucoma
• Ocular hypertension
ONO PHARMACEUTICAL
 
P1
P2
P3
NDA filed
Approved
Launched
U.S.
Japan
Europe
(Ex. study)
Atropine sulfate DE-127 (STN1012700)

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.

Indication
Original/Licensor
Myopia
Singapore Health Services, Nanyang Technological University
 
P1
P2
P3
NDA filed
Approved
Launched
Japan
(Phase 2/3)
China
(Phase 2/3)
Asia
Atropine sulfate SYD-101 (STN1012701)

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.

Indication
Original/Licensor
Myopia
Sydnexis Inc.
 
P1
P2
P3
NDA filed
Approved
Launched
Europe
Glaucoma implant device DE-128 (STN2000100)

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.

Indication
Original/Licensor
Glaucoma
Original
 
P1
P2
P3
NDA filed
Approved
Launched
Japan
July 2022
Europe
Apr 2019
Asia
Sep 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.

Latanoprost DE-130A (STN1013001)

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.

Indication
Original/Licensor
Glaucoma
• Ocular hypertension
Original
 
P1
P2
P3
NDA filed
Approved
Launched
Europe
Sept 2022
Asia
AFDX0250BS (STN1013400)

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.

Indication
Original/Licensor
Myopia
Boehringer Ingelheim
 
P1
P2
P3
NDA filed
Approved
Launched
Japan
Ursodeoxycholic acid (STN1013600)

Improvement of presbyopia by improving lens elasticity. Completed Phase 1 in April 2022 in Japan.

Indication
Original/Licensor
Presbyopia
Original
 
P1
P2
P3
NDA filed
Approved
Launched
Japan
Oxymetazoline hydrochloride (STN1013800)

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

Indication
Original/Licensor
Ptosis
RVL Pharmaceuticals
 
P1
P2
P3
NDA filed
Approved
Launched
Japan
Netarsudil mesylate AR-13324 (STN1013900)

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.

Indication
Original/Licensor
Glaucoma
• Ocular hypertension
Aerie
 
P1
P2
P3
NDA filed
Approved
Launched
Japan
Europe
Asia
Mar 2022
Netarsudil mesilate / latanoprost PG-324 (STN1014000)

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.

Indication
Original/Licensor
Glaucoma
• Ocular hypertension
Aerie
 
P1
P2
P3
NDA filed
Approved
Launched
Europe
Asia
May 2022

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.