A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Three-arm Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tarcocimab Tedromer and Tabirafusp Tedromer Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)

A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants with Neovascular (Wet) Age-related Macular Degeneration (wAMD)

Start Date23 Aug 2024

Sponsor / Collaborator

Kodiak Sciences, Inc.

NCT06270836

/ Active, not recruitingPhase 3

A Prospective, Randomized, Double-masked, Sham-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tarcocimab Tedromer in Participants With Diabetic Retinopathy (DR) - GLOW2

This study will demonstrate that tarcocimab 5 mg is superior to sham treatment in participants with DR.

Start Date01 May 2024

Sponsor / Collaborator

Kodiak Sciences, Inc.

NCT05066230

/ TerminatedPhase 3

A Prospective, Randomized, Double-masked, Sham-controlled, Multicenter, Two-arm Phase3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy

This Phase 3 Study will evaluate the efficacy and safety of KSI-301 in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR).

Start Date07 Sep 2021

Sponsor / Collaborator

Kodiak Sciences, Inc.

100 Clinical Results associated with Tarcocimab tedromer

100 Translational Medicine associated with Tarcocimab tedromer

100 Patents (Medical) associated with Tarcocimab tedromer

Literatures (Medical) associated with Tarcocimab tedromer

01 Jan 2025·EYE

Exploring new horizons in neovascular age-related macular degeneration: novel mechanisms of action and future therapeutic avenues

Review

Author: Shirian, Jonathan D ; Shirian, Jonathan D. ; Singh, Rishi P. ; Shukla, Priya ; Singh, Rishi P

Abstract:

Neovascular age-related macular degeneration (nAMD) can lead to significant vision impairment through the growth of abnormal neovascular membranes in the choroid. Despite advancements with current anti-vascular endothelial growth factor (VEGF) therapies, challenges such as frequent injections, inadequate response, and patient-related concerns persist. Emerging therapeutics aim to reduce vision-loss through a variety of mechanisms. Gene therapies, including RGX-314 and Ixo-vec, express an anti-VEGF protein, and 4D-150, expresses an anti-VEGF protein and a VEGF-C inhibitory miRNA. Anti-VEGF associated therapeutics include OPT-302, targeting VEGF-C and VEGF-D, BI 836880, which inhibits VEGF-A and Ang-2 activity, and Tarcocimab tedromer, inhibiting all VEGF-A isoforms. Agents with novel mechanisms of action include UBX1325, which inhibits an anti-apoptotic protein, Restoret (EYE103), a Wnt agonist, and the tyrosine kinase inhibitors, EYP-1901, OTX-TKI, CLS-AX, and KHK4951.

02 Oct 2024·Expert Opinion on Drug Metabolism & Toxicology

Intraocular drugs: pharmacokinetic strategies and the influence on efficacy and durability

Review

Author: Stewart, Michael W.

INTRODUCTION:

The modern treatment of chorioretinal vascular diseases follows the recent development and rapid adoption of drugs that inhibit vascular endothelial growth factor (VEGF). All anti-VEGF drugs are delivered intravitreally, with clinical behavior, including efficacy, durability, and safety, largely determined by their pharmacokinetic properties.

AREAS COVERED:

Properties of these new drugs include additional binding targets (placental growth factor (PlGF) and angiopoietin 2 (Ang 2)), binding affinity, potency, intravitreal half-life, and increased molar dose. A PubMed search for 'pharmacokinetics of anti-VEGF drugs' was performed from 2000 to 2023. Relevant studies were reviewed and referred to in the manuscript.

EXPERT OPINION:

Early developers concentrated on improving efficacy, but since maximum efficacy with VEGF inhibition has been reached, development has pivoted to extending the duration of action. Durability strategies include inhibiting additional pathways (faricimab), increasing molar dose (abicipar, brolucizumab, faricimab, and aflibercept 8 mg), and prolonging the intravitreal half-life (abicipar and KSI-301). Recent phase 3 trials demonstrated modest improvements in durability, but failures that might be attributed to these strategies (conjugation and manufacturing processes) have occurred. Future drug development focuses on extending duration of action with implantable reservoirs (ranibizumab port delivery system), sustained release devices (tyrosine kinase inhibitors), and gene therapy.

03 Oct 2022·Expert opinion on biological therapy

Efficacy and safety of intravitreal anti-VEGF therapy in diabetic retinopathy: what we have learned and what should we learn further?

Review

Author: Trong Tuong Than, Ngoc ; Hassan, Muhammad ; Akhavanrezayat, Amir ; Doan, Hien Luong ; Halim, Muhammad Sohail ; Pham, Brandon Huy ; Do, Diana V ; Chea, Sophaktra ; Matsumiya, Wataru ; Uludag, Gunay ; Nguyen, Quan Dong

INTRODUCTION:

Diabetic retinopathy (DR) is one of the most frequent microvascular complications of diabetes that can lead to blindness. Laser treatment has been the gold standard treatment for diabetic macular edema (DME) and proliferative diabetic retinopathy (PDR) for many years. Recently, the role of vascular endothelial growth factor (VEGF) has been established in the pathogenesis of DR, and the use of intravitreal anti-VEGF therapy has gained popularity for the management of DR.

AREAS COVERED:

This review includes a brief overview of the efficacy and safety of currently available (bevacizumab, ranibizumab, and aflibercept) and potential future (brolucizumab, faricimab, and KSI-301) anti-VEGF agents in patients with DR based mainly on publicly available data from phase 1, 2 and 3 clinical trials.

EXPERT OPINION:

Clinical trials investigating the efficacy of intravitreal bevacizumab, ranibizumab, and aflibercept injections demonstrated favorable functional and anatomical outcomes in patients with DME. Moreover, the use of these anti-VEGF agents showed a significant improvement in the severity of DR. Recent clinical research for future anti-VEGF molecules aims to provide higher target-protein binding affinity and prolonged therapeutic effect. Brolucizumab, faricimab, and KSI-301 are three novel anti-VEGF agents that demonstrate promising data for the management of DME and potentially DR.

News (Medical) associated with Tarcocimab tedromer

06 Feb 2026

·www.prnewswire.com

Final APEX Phase 1b Clinical Results for Kodiak's KSI-101 in Macular Edema Secondary to Inflammation to be Presented at Angiogenesis 2026

Feb. 4, 2026-- Kodiak Sciences Inc. (Nasdaq: KOD), a precommercial retina focused biotechnology company committed to researching, developing and commercializing transformative therapeutics, announced today participation at the virtual Angiogenesis (Angiogenesis, Exudation, and Degeneration) annual meeting on February 7, 2026. Dr. Sumit Sharma, retina and uveitis specialist at the Cole Eye Institute, will present first-time end-of-study clinical results, including Week 24 data, from the Phase 1b APEX study in patients with macular edema secondary to inflammation (MESI). Presentation title: Bispecific Trap-antibody Inhibiting Interleukin-6 and Vascular Endothelial Growth Factor (KSI-101): Phase 1b APEX Study in Patients with Macular Edema Secondary to Inflammation (MESI) Time: 5:15 PM EST The presentation will be posted at the start of the event on the "Events and Presentations" section of Kodiak's website at http://ir.kodiak.com/. "This year's Angiogenesis meeting marks the first presentation of end-of-study results from the APEX study for KSI-101. These final data continue to demonstrate robust anatomic and visual improvements in patients with MESI, regardless of the underlying etiology or location of inflammation, further supporting the clinical efficacy and safety profile of KSI-101 observed to date. With PEAK and PINNACLE Phase 3 studies actively enrolling, these final results strengthen our confidence in KSI-101's potential to become a safe, first-line unifying therapy for all causes of MESI," said Victor Perlroth, M.D., Chairman and CEO of Kodiak Sciences. KSI-101 is a novel, potent and high strength (100 mg/mL) bispecific protein targeting IL-6 and VEGF. We are developing KSI-101 for patients with macular edema (retinal fluid) secondary to inflammation (MESI). MESI is a heterogenous group of diseases that clinically present with macular edema and visual impairment which are caused by a common pathophysiology–inflammation and blood retinal barrier disruption. The clinical presentation of retinal fluid and visual impairment is a mainstay in these patients, irrespective of the location of the inflammation inside of the eye (anterior, intermediate, posterior or all intraocular compartments) or the specific etiology (defined autoimmune associated, idiopathic, post-procedural, or inflammatory choroidal neovascularization). Currently there are no available intravitreal biologic therapies addressing the spectrum of MESI diseases. We believe that MESI represents a new market segment separate from the established anti-VEGF market. We have completed enrollment in our dose-finding Phase 1b study APEX. The APEX study evaluates KSI-101 in two cohorts, Cohort 1 in patients with diabetic macular edema (DME) and Cohort 2 in patients with macular edema secondary to inflammation (MESI). APEX demonstrated that KSI-101 provides meaningful visual and anatomical gains in both DME and MESI and that KSI-101 is well tolerated. Meaningful treatment responses were seen in the MESI population, irrespective of the location of inflammation and specific MESI etiology, opening up the potential for KSI-101 to become a unifying treatment for this patient population. Based on APEX, the top two dose levels tested were selected to advance into the Phase 3 program. The PEAK and PINNACLE Phase 3 studies are actively enrolling MESI subjects at the 5 mg and 10 mg dose levels versus sham. Kodiak Sciences (Nasdaq: KOD) is a precommercial retina focused biotechnology company committed to researching, developing and commercializing transformative therapeutics. We are focused on bringing new science to the design and manufacture of next generation retinal medicines to prevent and treat the leading causes of blindness globally. We are developing a portfolio of three late-stage clinical programs. Tarcocimab and KSI-501 are being explored in two BLA-facing Phase 3 studies in the retinal vascular diseases, targeting the $15 billion anti-VEGF marketplace, with topline data readouts expected in 1Q 2026 and 3Q 2026. KSI-101 is a bispecific protein being explored in two BLA-facing Phase 3 studies in Macular Edema Secondary to Inflammation (MESI), with topline data readouts expected in 4Q 2026 (PEAK) and 2Q 2027 (PINNACLE). Kodiak®, Kodiak Sciences®, ABC®, ABC Platform™ and the Kodiak logo are registered trademarks or trademarks of Kodiak Sciences Inc. in various global jurisdictions. The content above comes from the network. if any infringement, please contact us to modify.

Clinical Result

19 Dec 2025

·www.prnewswire.com

Kodiak Sciences Announces Closing of $184 Million Public Offering of Common Stock including Full Exercise of Underwriters' Option to Purchase Additional Shares

PALO ALTO, Calif., Dec. 18, 2025 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a precommercial retina focused biotechnology company committed to researching, developing and commercializing transformative therapeutics, today announced the closing of its previously announced underwritten public offering of 8,000,000 shares of its common stock, which includes 1,043,478 shares sold pursuant to the underwriters' exercise in full of their option to purchase additional shares, at a price to the public of $23.00 per share. The gross proceeds to Kodiak Sciences from the offering were approximately $184 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by Kodiak Sciences. J.P. Morgan, Jefferies, Evercore ISI and UBS Investment Bank acted as joint book-running managers for the offering. Dr. Victor Perlroth, M.D., Chairman and CEO of Kodiak commented, "we are pleased to have successfully completed this public offering, which strengthens our financial position as we execute through important Phase 3 topline readouts for all three of our late-stage clinical assets of KSI-101, KSI-501 and tarcocimab. The transaction was thoughtfully structured, reflecting our disciplined approach to capital formation and our continued focus on long-term shareholder value." The shares described above were offered by Kodiak Sciences pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Kodiak Sciences with the Securities and Exchange Commission (the "SEC") and that was declared effective by the SEC on June 2, 2023. A final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available for free on the SEC's website located at . Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at [email protected] and [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, telephone: (877) 821-7388, or by emailing [email protected]; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at 888-474-0200, or by email at [email protected]; or UBS Securities LLC, Attention: Prospectus Department, UBS Investment Bank, 11 Madison Avenue, New York, New York 10010 or by email at [email protected]. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Kodiak Sciences Inc. Kodiak Sciences (Nasdaq: KOD) is a precommercial retina focused biotechnology company committed to researching, developing and commercializing transformative therapeutics. We are focused on bringing new science to the design and manufacture of next generation retinal medicines to prevent and treat the leading causes of blindness globally. Our ABC® Platform uses molecular engineering to merge the fields of protein-based and chemistry-based therapies and has been at the core of Kodiak's discovery engine. We are developing a portfolio of three late-stage clinical programs. Tarcocimab and KSI-501 are being explored in two BLA-facing Phase 3 studies in the retinal vascular diseases. KSI-101 is a bispecific protein being explored in two Phase 3 studies in Macular Edema Secondary to Inflammation (MESI). Kodiak®, Kodiak Sciences®, ABC™, ABC Platform™ and the Kodiak logo are registered trademarks or trademarks of Kodiak Sciences Inc. in various global jurisdictions. SOURCE Kodiak Sciences Inc. 21% more press release views with Request a Demo

Phase 3

18 Dec 2025

·ir.kodiak.com

Kodiak Sciences Announces Closing of $184 Million Public Offering of Common Stock including Full Exercise of Underwriters' Option to Purchase Additional Shares

PALO ALTO, Calif., Dec. 18, 2025 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a precommercial retina focused biotechnology company committed to researching, developing and commercializing transformative therapeutics, today announced the closing of its previously announced underwritten public offering of 8,000,000 shares of its common stock, which includes 1,043,478 shares sold pursuant to the underwriters' exercise in full of their option to purchase additional shares, at a price to the public of $23.00 per share. The gross proceeds to Kodiak Sciences from the offering were approximately $184 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by Kodiak Sciences. J.P. Morgan, Jefferies, Evercore ISI and UBS Investment Bank acted as joint book-running managers for the offering. Dr. Victor Perlroth, M.D., Chairman and CEO of Kodiak commented, "we are pleased to have successfully completed this public offering, which strengthens our financial position as we execute through important Phase 3 topline readouts for all three of our late-stage clinical assets of KSI-101, KSI-501 and tarcocimab. The transaction was thoughtfully structured, reflecting our disciplined approach to capital formation and our continued focus on long-term shareholder value." The shares described above were offered by Kodiak Sciences pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Kodiak Sciences with the Securities and Exchange Commission (the "SEC") and that was declared effective by the SEC on June 2, 2023. A final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available for free on the SEC's website located at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at prospectus-eq_fi@jpmchase.com and postsalemanualrequests@broadridge.com; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, telephone: (877) 821-7388, or by emailing prospectus_department@jefferies.com; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at 888-474-0200, or by email at ecm.prospectus@evercore.com; or UBS Securities LLC, Attention: Prospectus Department, UBS Investment Bank, 11 Madison Avenue, New York, New York 10010 or by email at ol-prospectus-request@ubs.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Kodiak Sciences Inc. Kodiak Sciences (Nasdaq: KOD) is a precommercial retina focused biotechnology company committed to researching, developing and commercializing transformative therapeutics. We are focused on bringing new science to the design and manufacture of next generation retinal medicines to prevent and treat the leading causes of blindness globally. Our ABC® Platform uses molecular engineering to merge the fields of protein-based and chemistry-based therapies and has been at the core of Kodiak's discovery engine. We are developing a portfolio of three late-stage clinical programs. Tarcocimab and KSI-501 are being explored in two BLA-facing Phase 3 studies in the retinal vascular diseases. KSI-101 is a bispecific protein being explored in two Phase 3 studies in Macular Edema Secondary to Inflammation (MESI). Kodiak®, Kodiak Sciences®, ABC™, ABC Platform™ and the Kodiak logo are registered trademarks or trademarks of Kodiak Sciences Inc. in various global jurisdictions. View original content:https://www.prnewswire.com/news-releases/kodiak-sciences-announces-closing-of-184-million-public-offering-of-common-stock-including-full-exercise-of-underwriters-option-to-purchase-additional-shares-302646525.html SOURCE Kodiak Sciences Inc. John Borgeson, Executive Vice President and Chief Financial Officer, Tel (650) 281-0850, ir@kodiak.com

Phase 3

100 Deals associated with Tarcocimab tedromer

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Nonproliferative diabetic retinopathy	Phase 3	Latvia	Kodiak Sciences, Inc.	27 Aug 2021
Wet age-related macular degeneration	Phase 3	Germany	Kodiak Sciences, Inc.	25 Nov 2020
Diabetic macular oedema	Phase 3	United States	Kodiak Sciences, Inc.	30 Sep 2020
Diabetic macular oedema	Phase 3	Czechia	Kodiak Sciences, Inc.	30 Sep 2020
Diabetic macular oedema	Phase 3	France	Kodiak Sciences, Inc.	30 Sep 2020
Diabetic macular oedema	Phase 3	Germany	Kodiak Sciences, Inc.	30 Sep 2020
Diabetic macular oedema	Phase 3	Hungary	Kodiak Sciences, Inc.	30 Sep 2020
Diabetic macular oedema	Phase 3	Israel	Kodiak Sciences, Inc.	30 Sep 2020
Diabetic macular oedema	Phase 3	Italy	Kodiak Sciences, Inc.	30 Sep 2020
Diabetic macular oedema	Phase 3	Latvia	Kodiak Sciences, Inc.	30 Sep 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04603937 (GLIMMER, CTgov)	Phase 3	Diabetic macular oedema \| Vision, Low	459	Sham Procedure+KSI-301 (KSI-301 (Arm A))	vkfthcvrpm(bizvnesswa) = qowvgontxt oedagefwoi (lppvfbzinb, 0.80) View more	-	22 Aug 2024
				Sham Procedure+Aflibercept (Aflibercept (Arm B))	vkfthcvrpm(bizvnesswa) = thwyapevnz oedagefwoi (lppvfbzinb, 0.81) View more
NCT04611152 (GLEAM, CTgov)	Phase 3	Diabetic macular oedema \| Vision, Low	460	Sham Procedure+KSI-301 (KSI-301 (Arm A))	slgnxnvtha(yvluhbpmgb) = aoadpixelq oouaulkhuv (gaqvmtnhfg, 0.83) View more	-	22 Aug 2024
				Sham Procedure+Aflibercept (Aflibercept (Arm B))	slgnxnvtha(yvluhbpmgb) = lhgybtwdxw oouaulkhuv (gaqvmtnhfg, 0.85) View more
NCT04049266 (DAZZLE, CTgov)	Phase 2/3	Wet age-related macular degeneration \| Wet Macular Degeneration	559	Sham Procedure+KSI-301 (KSI-301 5 mg)	jqnpwqijfl = xhujeffooh wzhvlsupft (wjlkmesnwc, zcdzfcmwaz - rayhmacgeh) View more	-	18 Jul 2024
				Sham Procedure+Aflibercept (Aflibercept 2 mg)	jqnpwqijfl = lwkrutouop wzhvlsupft (wjlkmesnwc, iijqaplzqn - ntaojgozip) View more
NCT04592419 (BEACON, CTgov)	Phase 3	Retinal Vein Occlusion \| Macular Edema \| Vision, Low	568	Sham Procedure+KSI-301 (KSI-301 (Arm A))	moomqrrnnd(ntlqfaecwb) = wwevcgqxvp wwnhxeoqie (bqmqrvqzmu, .81) View more	-	06 Jun 2024
				Sham Procedure+Aflibercept (Aflibercept (Arm B))	moomqrrnnd(ntlqfaecwb) = ogydoxmotf wwnhxeoqie (bqmqrvqzmu, .79) View more
NCT04964089 (DAYLIGHT, CTgov)	Phase 3	Wet age-related macular degeneration	557	KSI-301 (KSI-301 (Treatment Group A))	lekahoqubi(gthnklqoah) = jsmhadhomw mqkigrvgtd (tuckadsbto, 0.78) View more	-	02 May 2024
				Sham Procedure+Aflibercept (Aflibercept (Treatment Group B))	lekahoqubi(gthnklqoah) = xwfvubtlls mqkigrvgtd (tuckadsbto, 0.76) View more
NCT05066230 (GLOW, PRNewswire) Manual	Phase 3	Nonproliferative diabetic retinopathy	253	tarcocimab tedromer	ksrfnmqwpl(qsnzualosv) = odcgkekeaa pwavftngci (jcjvejzptg ) View more	Positive	06 Nov 2023
				placebo	ksrfnmqwpl(qsnzualosv) = djtyuqoluk pwavftngci (jcjvejzptg ) View more
NCT04592419 (BEACON, Corporate Publications) Manual	Phase 3	Retinal Vein Occlusion	568	tarcocimab tedromer	lxpubbryxm(zqwfylupbq): P-Value = 0.0004 View more	Non-inferior	08 Aug 2022
				Aflibercept
NCT04049266 (DAZZLE, Corporate Publications) Manual	Phase 2/3	Wet age-related macular degeneration First line	559	Tarcocimab tedromer	nsgbddlfwl(yjhhoepwoy) = vjfmhpcvtx cbhfaiwmlm (vjaykmrdvw ) View more	Negative	23 Feb 2022
				Aflibercept	nsgbddlfwl(yjhhoepwoy) = ykoeqocqkr cbhfaiwmlm (vjaykmrdvw ) View more
NCT03790852 (ARVO2020)	Phase 1	Diabetic macular oedema \| Retinal Vein Occlusion \| Wet age-related macular degeneration	109	KSI-301 2.5 mg	vcrohbnoxu(zobonhdhbl) = no drug-related adverse events after 338 doses ypkieekahi (cpxbytkigb ) View more	-	01 Jun 2020
				KSI-301 5 mg

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