Japanese multinational pharmaceutical company, third largest in Asia and among top 20 globally by revenue; focused on oncology, rare diseases, neuroscience, gastroenterology, plasma-derived therapies, and vaccines.
Clinical Trials
430
37 active
Approvals
44
Total approvals
Agencies
2
Regulatory bodies
Founded
1781
Active, not recruiting
29
6.7%
Completed
228
53.0%
Not yet recruiting
8
1.9%
Recruiting
33
7.7%
Suspended
1
0.2%
Terminated
1
0.2%
- Innovent Biologics has expanded the global Phase 3 MarsLight-11 trial of IBI363/TAK-928 to add a second substudy enrolling patients with non-squamous NSCLC. - Each substudy compares IBI363 monotherapy against docetaxel in unresectable, locally advanced or metastatic NSCLC that progressed on platinum chemotherapy and anti-PD-1/PD-L1 therapy. - IBI363/TAK-928 is a potential first-in-class alpha-biased IL-2/PD-1 bispecific fusion protein co-developed globally by Innovent and Takeda under an October 2025 agreement. - The candidate holds two FDA Fast Track Designations and three China NMPA Breakthrough Therapy Designations, and is also in pivotal studies in melanoma and colorectal cancer.
- Eli Lilly will pay InnoCare Pharma up to $100 million in upfront and near-term payments under a strategic research collaboration and license agreement. - InnoCare is eligible for up to approximately $3.25 billion in development and commercial milestone payments plus single-digit tiered royalties on annual net product sales. - InnoCare will use its proprietary drug discovery platform to discover and advance compounds against up to five undisclosed targets addressing unmet medical needs. - The partners have not disclosed the specific targets or therapeutic areas, and InnoCare's pipeline spans cancer and autoimmune diseases with three approved drugs.
- Takeda will present late-breaking Phase 3 G-HOPE-001 data for arcotatug tavatecan (TAK-921), a Claudin 18.2-targeted antibody-drug conjugate, in previously treated advanced gastric and gastroesophageal junction adenocarcinoma. - The G-HOPE-001 study was conducted in Japan and China, and pending final results, its data could support a potential regulatory filing for this indication in Japan. - Two ESMO presentations will cover TAK-928, a first-in-class PD-1/alpha-biased IL-2 bispecific fusion protein, in immunotherapy-resistant and first-line non-small cell lung cancer. - Takeda is expanding the global Phase 3 MarsLight-11 study of TAK-928 versus docetaxel with a new sub-trial in non-squamous NSCLC, alongside real-world analyses of brigatinib and fruquintinib.
- Iambic Therapeutics filed an S-1 with the SEC on September 21, 2026 to list on the Nasdaq Global Select Market under the ticker IAM. - Proceeds will advance clinical development of lead HER2 inhibitor IAM1363 plus preclinical candidates IAM217 and IAM-C1, alongside general corporate purposes. - IAM1363, an oral pan-mutant brain-penetrant HER2 inhibitor, is in a Phase 1/1b basket study with a registrational trial planned as early as 2027. - The company reported $12.8 million in collaboration revenue for the six months ended June 30, 2026, against a $50.1 million net loss for the same period.
- Takeda Biopharmaceuticals India and Dr Reddy's Laboratories have entered a distribution agreement covering QDENGA, India's first approved dengue vaccine, in the country's private market. - Dr Reddy's will exclusively promote and distribute QDENGA for paediatric and adult vaccination, with availability anticipated in the first half of 2027 pending local authority processes. - The deal follows CDSCO marketing authorisation in July 2026 for individuals aged 4 to 60 years, and Takeda retains public-market rights plus medical and brand oversight. - Dengue cases in India have risen 11-fold over two decades, and a nationwide ICMR surveillance study found all four serotypes co-circulating, with 1 in 14 patients infected with multiple serotypes.
- Takeda received Japanese marketing approval on September 16 for Elahere, an antibody-drug conjugate targeting folate receptor alpha, in platinum-resistant recurrent ovarian cancer. - Elahere, or mirvetuximab soravtansine, is the first and only antibody-drug conjugate approved in Japan for this folate receptor alpha-positive indication. - The approval rests on the Phase 3 MIRASOL and SORAYA trials plus the domestic Phase 1/2 TAK-853-1501 study, with MIRASOL showing progression-free and overall survival benefit.
- Novo Nordisk has entered a collaboration with Anthropic to apply artificial intelligence across its drug discovery and development workflows, with no financial terms disclosed. - The Danish drugmaker will initially test Anthropic's Claude Science on selected R&D workflows where the partners expect the greatest scientific impact. - Novo will also use Anthropic's frontier models to strengthen AI-driven software development, which it calls a key enabler for scaling AI company-wide. - The deal extends Novo's 2026 AI partnerships, following agreements with OpenAI in April and Amazon Web Services in August.
- The FDA accepted Takeda's New Drug Application under Priority Review for zasocitinib (TAK-279) in adults with moderate-to-severe plaque psoriasis, with a PDUFA date in the first quarter of 2027. - The filing rests on pivotal Phase 3 LATITUDE PsO 3001 and 3002 trials in which all co-primary and 44 ranked secondary endpoints were met across nearly 3,000 patients. - At week 16, roughly 70% of zasocitinib-treated patients achieved sPGA 0/1 versus 11-13% on placebo and 30-32% on apremilast, with PASI 75 rates of 71-76% versus 12% and 33-37%. - The European Medicines Agency has also accepted Takeda's marketing authorization application for zasocitinib, and the company plans further global filings for plaque psoriasis.
- Insilico Medicine dosed the first patient with Rentosertib in the Phase III GENESIS-IPF-3 trial for idiopathic pulmonary fibrosis at Peking Union Medical College Hospital. - The 52-week randomized, double-blind, placebo-controlled study will enroll 320 patients across 47 centers in China, with FVC decline as the primary endpoint. - Rentosertib is a potentially first-in-class small molecule targeting TNIK, a fibrosis pathway identified through AI-driven discovery and never previously linked to fibrosis. - Insilico reported first-half 2026 revenue of about $106 million, a 287% year-over-year increase, and its first profitable half-year since listing.
- The FDA has approved Orzeyful (oveporexton), the first drug designed to mimic orexin, the brain peptide missing in people with narcolepsy type 1. - In two phase 3 trials, oveporexton roughly doubled sleep latency versus placebo and cut weekly cataplexy rates by up to 88.8%. - Adverse events occurred in 86 to 89 percent of oveporexton-treated participants, most commonly increased urinary frequency and transient insomnia. - Alkermes and Eli Lilly are pursuing similar orexin-targeting programs, with Lilly agreeing to pay up to $7.8bn for Centessa Pharmaceuticals.
