This section highlights FDA-related milestones and regulatory updates for drugs developed by Takeda Pharmaceutical (TAK).
Over the past two years, Takeda Pharmaceutical has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ADZYNMA®, brentuximab, CABOMETYX, FRUZAQLA, HYQVIA, LIVTENCITY®, and TAK-861. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ADZYNMA® - FDA Regulatory Timeline and Events
ADZYNMA® is a drug developed by Takeda Pharmaceutical for the following indication: For Congenital Thrombotic Thrombocytopenic Purpura (cTTP).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ADZYNMA®
- Announced Date:
- August 7, 2024
- Indication:
- For Congenital Thrombotic Thrombocytopenic Purpura (cTTP)
Announcement
Takeda announced that the European Commission (EC) approved ADZYNMA®▼ (recombinant ADAMTS13) for the treatment of ADAMTS13 deficiency in children and adult patients with congenital thrombotic thrombocytopenic purpura (cTTP).3
AI Summary
Takeda announced that the European Commission has approved ADZYNMA® (recombinant ADAMTS13) for the treatment of ADAMTS13 deficiency in children and adults with congenital thrombotic thrombocytopenic purpura (cTTP). This approval marks a significant milestone as ADZYNMA becomes the first and only enzyme replacement therapy in the European Union specifically designed for cTTP. The decision was based on comprehensive evidence from the first randomized, controlled Phase 3 trial in cTTP, which showed that patients receiving ADZYNMA experienced no acute TTP events during prophylactic treatment, in contrast to those on plasma-based therapies. The trial results also demonstrated that ADZYNMA has a favorable safety profile with common reactions including headache and nausea. This development provides a new treatment option for patients facing a life-threatening disorder with limited alternatives and underscores Takeda's commitment to advancing care in rare blood disorders.
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brentuximab vedotin - FDA Regulatory Timeline and Events
brentuximab vedotin is a drug developed by Takeda Pharmaceutical for the following indication: In adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- brentuximab vedotin
- Announced Date:
- June 3, 2025
- Indication:
- In adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma.
Announcement
Takeda announced that the European Commission (EC) approved ADCETRIS® (brentuximab vedotin) in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) – a chemotherapy regimen – in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma.
AI Summary
Takeda announced that the European Commission (EC) has approved ADCETRIS® (brentuximab vedotin) in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, and dexamethasone (ECADD) for adult patients with newly diagnosed Stage IIb with risk factors, III, or IV Hodgkin lymphoma. This decision follows a positive opinion from the Committee for Medicinal Products for Human Use and is based on results from the Phase 3 HD21 trial.
In the trial, the ADCETRIS-based regimen, known as BrECADD, demonstrated a superior safety profile compared to the standard eBEACOPP regimen while maintaining effective progression-free survival. The new combination offers physicians greater treatment flexibility and may improve long-term outcomes. This approval marks a significant advancement in expanding treatment options for frontline Hodgkin lymphoma care in the European Union.
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CABOMETYX (cabozantinib) + OPDIVO (nivolumab) - FDA Regulatory Timeline and Events
CABOMETYX (cabozantinib) + OPDIVO (nivolumab) is a drug developed by Takeda Pharmaceutical for the following indication: Unresectable or Metastatic Renal Cell Carcinoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CABOMETYX (cabozantinib) + OPDIVO (nivolumab)
- Announced Date:
- February 15, 2025
- Indication:
- Unresectable or Metastatic Renal Cell Carcinoma
Announcement
Exelixis, Inc announced final results from the phase 3 CheckMate -9ER pivotal trial evaluating CABOMETYX® (cabozantinib) in combination with Opdivo® (nivolumab) versus sunitinib for patients with previously untreated advanced renal cell carcinoma (RCC).
AI Summary
Exelixis, Inc. announced the final results from its phase 3 CheckMate‑9ER pivotal trial comparing CABOMETYX® (cabozantinib) combined with Opdivo® (nivolumab) to sunitinib for patients with previously untreated advanced renal cell carcinoma (RCC). After more than five years of follow‐up, the combination therapy demonstrated a lasting survival benefit over sunitinib. The trial showed that patients receiving CABOMETYX plus Opdivo experienced improved progression‐free survival, with a hazard ratio of 0.58, and overall survival, with a hazard ratio of 0.79. Additionally, subgroup analyses revealed that the long-term efficacy was maintained regardless of metastases location, including liver, bone, and lung. These positive findings support the use of the CABOMETYX and Opdivo regimen as a valuable first-line treatment option, offering durable clinical benefits for patients with advanced RCC.
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FRUZAQLA (fruquintinib) - FDA Regulatory Timeline and Events
FRUZAQLA (fruquintinib) is a drug developed by Takeda Pharmaceutical for the following indication: For Metastatic Colorectal Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- FRUZAQLA (fruquintinib)
- Announced Date:
- January 21, 2025
- Indication:
- For Metastatic Colorectal Cancer
Announcement
Takeda Canada Inc is pleased to announce that Health Canada has provided market authorization for FRUZAQLA™ (fruquintinib capsules), indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with or are not considered candidates for available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF agent, an anti-EGFR agent (if RAS wild-type), and either trifluridine-tipiracil or regorafenib.1
AI Summary
Takeda Canada Inc. announced that Health Canada has authorized the market for FRUZAQLA™ (fruquintinib capsules). This new treatment is designed for adult patients with metastatic colorectal cancer (mCRC) who have already received, or are not eligible for, standard therapies. These therapies include fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, along with an anti-VEGF agent, an anti-EGFR agent (if RAS wild-type), and either trifluridine-tipiracil or regorafenib.
The approval is backed by positive reimbursement recommendations from Canada’s Drug Agency (CDA-AMC) and the Institut national d’excellence en santé et services sociaux (INESSS). FRUZAQLA works by inhibiting VEGFR-1, -2, and -3, which helps prevent tumors from making new blood vessels, thereby slowing down cancer progression. This new option provides hope and an additional treatment opportunity for Canadian patients battling mCRC.
Read Announcement- Drug:
- FRUZAQLA (fruquintinib)
- Announced Date:
- September 24, 2024
- Indication:
- For Metastatic Colorectal Cancer
Announcement
Takeda announced that it has received approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market FRUZAQLA Capsules 1mg/5mg (generic name: fruquintinib), a selective oral inhibitor of vascular endothelial growth factor receptor (VEGFR) -1, -2 and -3, for the treatment of advanced or recurrent colorectal cancer (CRC) that is neither curable nor resectable and that has progressed after chemotherapy.
AI Summary
Takeda announced that it has received approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market FRUZAQLA Capsules 1mg/5mg (fruquintinib). This selective oral inhibitor targets VEGFR‐1, ‐2, and ‐3, and is designed for advanced or recurrent colorectal cancer that is neither curable nor resectable and has progressed after chemotherapy. The approval is based on positive data from the global Phase 3 FRESCO-2 trial, which showed significant improvements in overall survival and progression-free survival compared to placebo. The trial enrolled patients from multiple regions, including Japan, and demonstrated a manageable safety profile along with consistent efficacy regardless of prior treatment types. With this approval, Takeda solidifies its commitment to introducing innovative cancer therapies, offering renewed hope and improved treatment options for patients facing limited alternatives in advanced colorectal cancer.
Read Announcement - Drug:
- FRUZAQLA (fruquintinib)
- Announced Date:
- June 21, 2024
- Indication:
- For Metastatic Colorectal Cancer
Announcement
Takeda announced that the European Commission (EC) approved FRUZAQLA (fruquintinib) as a monotherapy indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine-tipiracil or regorafenib.
AI Summary
Takeda recently announced that the European Commission approved FRUZAQLA (fruquintinib) as a monotherapy for adult patients with metastatic colorectal cancer (mCRC) who have already received standard treatments. These treatments include fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, as well as anti-VEGF and anti-EGFR agents. The approval is specifically for patients whose disease has progressed on or who are unable to tolerate further treatment with trifluridine-tipiracil or regorafenib.
This decision, following the Committee for Medicinal Products for Human Use’s positive opinion, is based on encouraging results from the global Phase 3 FRESCO-2 trial. The study showed that FRUZAQLA improved key efficacy endpoints while maintaining a manageable safety profile. The approval marks the first novel targeted treatment option for mCRC in the European Union in over a decade, offering patients a chemotherapy-free, oral treatment that is effective regardless of biomarker status.
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HYQVIA - FDA Regulatory Timeline and Events
HYQVIA is a drug developed by Takeda Pharmaceutical for the following indication: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- HYQVIA
- Announced Date:
- December 27, 2024
- Indication:
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Announcement
Takeda announced that the Japanese Ministry of Health, Labour and Welfare has approved the use of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with agammaglobulinemia or hypogammaglobulinemia1, disorders characterized by very low or absent levels of antibodies and an increased risk of serious recurring infection caused by primary immunodeficiency (PID) or secondary immunodeficiency (SID)2.
AI Summary
Takeda announced that Japan’s Ministry of Health, Labour and Welfare has approved HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for treating patients with agammaglobulinemia or hypogammaglobulinemia. These conditions, marked by very low or absent levels of antibodies, raise the risk of serious recurring infections due to primary or secondary immunodeficiencies.
HYQVIA is the first and only facilitated subcutaneous immunoglobulin (fSCIG) therapy available in Japan. The product combines immunoglobulin and recombinant human hyaluronidase, which helps increase the dispersion and absorption of the infused fluid, allowing for larger volumes per dose. This results in a more flexible treatment schedule with less frequent dosing—every three or four weeks—in contrast to traditional subcutaneous therapies that require weekly or bi-weekly infusions.
Read Announcement- Drug:
- HYQVIA
- Announced Date:
- June 18, 2024
- Indication:
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Announcement
Takeda announced data from the Phase 3 ADVANCE-CIDP 3 clinical trial, a long-term extension study evaluating the safety and efficacy of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
AI Summary
Takeda announced new data from its Phase 3 ADVANCE-CIDP 3 clinical trial, a long‐term extension study that evaluated HYQVIA® in patients with chronic inflammatory demyelinating polyneuropathy (CIDP). The study, which is the longest extension trial in CIDP to date, enrolled 85 patients and showed that HYQVIA maintained a stable disease course with a low relapse rate. Results confirmed that HYQVIA has a favorable long-term safety and tolerability profile. Patients received a median treatment duration of 33 months, and most doses were administered every four weeks, offering the convenience of monthly treatment. This data supports HYQVIA’s effectiveness as a maintenance therapy for CIDP, potentially allowing self-administration at home after proper training. The findings will be further discussed at the Peripheral Nerve Society Annual Meeting in June 2024.
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LIVTENCITY® (maribavir) - FDA Regulatory Timeline and Events
LIVTENCITY® (maribavir) is a drug developed by Takeda Pharmaceutical for the following indication: For Post-Transplant Cytomegalovirus (CMV) Infection/Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LIVTENCITY® (maribavir)
- Announced Date:
- June 24, 2024
- Indication:
- For Post-Transplant Cytomegalovirus (CMV) Infection/Disease
Announcement
Takeda announced that LIVTENCITY® (maribavir) has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW)for post-transplant cytomegalovirus (CMV) infection/disease that is refractory to existing anti-CMV therapies.
AI Summary
Takeda announced that the Japanese Ministry of Health, Labour and Welfare has approved LIVTENCITY® (maribavir) for treating post-transplant cytomegalovirus (CMV) infections or diseases that do not respond to existing anti-CMV therapies. This approval marks LIVTENCITY as the first and only treatment in Japan that specifically targets and inhibits the UL97 protein kinase, a key enzyme for CMV replication. The drug offers a new therapeutic option for transplant patients facing challenging cases of CMV, which can lead to serious complications, including organ rejection and graft failure. Based on promising clinical data, including results from Phase 3 trials, Takeda is hopeful that LIVTENCITY will significantly improve treatment outcomes for patients who have not benefited from other available therapies, thereby transforming the management of post-transplant CMV infections in Japan.
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TAK-861 - FDA Regulatory Timeline and Events
TAK-861 is a drug developed by Takeda Pharmaceutical for the following indication: In patients with moderate to severe obstructive sleep apnea undergoing general anesthesia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TAK-861
- Announced Date:
- May 14, 2025
- Indication:
- In patients with moderate to severe obstructive sleep apnea undergoing general anesthesia.
Announcement
Takeda announced that the New England Journal of Medicine published data from the Phase 2b trial of oveporexton (TAK-861) in people with narcolepsy type 1 (NT1).
AI Summary
Takeda announced that the New England Journal of Medicine has published data from its Phase 2b clinical trial of oveporexton (TAK-861) in people with narcolepsy type 1 (NT1). The study examined the effectiveness of this investigational oral orexin receptor 2 agonist, which is designed to restore orexin signaling, addressing the root cause of NT1. Results showed statistically significant improvements in both primary and secondary endpoints compared to placebo. Most subjects achieved near normal levels of wakefulness, experienced fewer cataplexy events, and noticed meaningful improvements in overall quality of life. Additionally, oveporexton was generally found to be safe and well tolerated with mostly mild to moderate side effects. These encouraging outcomes support further development of this treatment approach, and Takeda anticipates a Phase 3 trial readout in 2025.
Read Announcement- Drug:
- TAK-861
- Announced Date:
- September 19, 2024
- Indication:
- In patients with moderate to severe obstructive sleep apnea undergoing general anesthesia.
Announcement
Takeda will present additional data from the Phase 2b trials (TAK-861-2001,TAK-861-2002) and long-term extension (LTE) study (TAK-861-2003) of TAK-861 in narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2) at Sleep Europe 2024, the 27th Congress of the European Sleep Research Society (ESRS), being held September 24-27, 2024 in Seville, Spain.
AI Summary
Takeda will present additional insights on its experimental drug TAK-861 at Sleep Europe 2024, the 27th Congress of the European Sleep Research Society, held in Seville, Spain from September 24-27, 2024. The company will showcase data from the Phase 2b trials (TAK-861-2001 and TAK-861-2002) along with results from the long-term extension study (TAK-861-2003). These studies focus on patients with narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2), and aim to demonstrate how TAK-861 may improve daily functioning by addressing issues related to sleep quality and cognition. This presentation will add valuable information on the drug’s performance, supporting its potential to offer a new treatment approach for narcolepsy by targeting the underlying orexin deficiency observed in NT1 patients.
Read Announcement- Drug:
- TAK-861
- Announced Date:
- June 3, 2024
- Estimated Event Date Range:
- January 1, 2024 - June 30, 2024
- Target Action Date:
- H1 2024
- Indication:
- In patients with moderate to severe obstructive sleep apnea undergoing general anesthesia.
Announcement
Takeda announced that Phase 3 Trials of TAK-861 to be Initiated in 1H FY2024
AI Summary
Takeda announced it will begin global Phase 3 trials of TAK-861 in narcolepsy type 1 (NT1) during the first half of fiscal year 2024. This announcement follows positive results from its Phase 2b trial, where TAK-861, the first oral orexin receptor 2 agonist developed to tackle the underlying orexin deficiency in NT1, showed statistically significant and clinically meaningful improvements. The trial demonstrated sustained benefits over eight weeks, with notable enhancements in sleep latency and other key measures of sleepiness and cataplexy. Additionally, TAK-861 was generally safe and well tolerated, with only mild to moderate adverse events reported. These promising findings lay the groundwork for the upcoming Phase 3 studies, which aim to confirm TAK-861’s potential as a transformative treatment option for patients suffering from NT1.
Read Announcement- Drug:
- TAK-861
- Announced Date:
- June 3, 2024
- Indication:
- In patients with moderate to severe obstructive sleep apnea undergoing general anesthesia.
Announcement
Takeda will present today positive results from its Phase 2b trial of TAK-861 in narcolepsy type 1 (NT1) as late-breaking data presentations at SLEEP 2024, the 38th annual meeting of the American Academy of Sleep Medicine and the Sleep Research Society.
AI Summary
Takeda announced that it will present positive results from its Phase 2b trial of TAK-861 for narcolepsy type 1 (NT1) at SLEEP 2024, the 38th annual meeting of the American Academy of Sleep Medicine and the Sleep Research Society. The trial demonstrated statistically significant and clinically meaningful improvements on the primary endpoint—the Maintenance of Wakefulness Test—as well as key secondary endpoints, including subjective sleepiness and cataplexy frequency, with benefits sustained over an 8‑week period.
TAK-861, an investigational oral orexin receptor 2 agonist, is designed to address the underlying cause of NT1 by targeting the orexin deficiency. The study also showed that TAK-861 was generally safe and well tolerated, reinforcing its potential as a transformative treatment option. Based on these promising results, Takeda plans to initiate global Phase 3 trials in the first half of fiscal year 2024.
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TAK-935 - FDA Regulatory Timeline and Events
TAK-935 is a drug developed by Takeda Pharmaceutical for the following indication: In Patients with Dravet Syndrome and Lennox-Gastaut Syndrome.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TAK-935
- Announced Date:
- June 17, 2024
- Indication:
- In Patients with Dravet Syndrome and Lennox-Gastaut Syndrome
Announcement
Takeda announced topline data from its SKYLINE and SKYWAY studies.
AI Summary
Takeda announced topline data from its Phase 3 SKYLINE and SKYWAY studies. In the SKYLINE study for patients with Dravet syndrome, soticlestat used as an add-on treatment narrowly missed the primary endpoint of reducing convulsive seizure frequency, with a p-value of 0.06. However, the study showed clinically meaningful benefits in multiple key secondary endpoints such as responder rates, caregiver and clinician global impressions, and seizure intensity and duration scores over 16 weeks. The SKYWAY study, which focused on Lennox-Gastaut syndrome, also did not meet its primary endpoint of reducing major motor drop seizures. Despite these results, soticlestat demonstrated a consistent and favorable safety and tolerability profile in both studies, and Takeda plans to discuss the totality of this data with regulatory authorities to determine the next steps.
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vedolizumab - FDA Regulatory Timeline and Events
vedolizumab is a drug developed by Takeda Pharmaceutical for the following indication: approved in intravenous (IV) and subcutaneous (SC) formulations.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- vedolizumab
- Announced Date:
- April 18, 2024
- Indication:
- approved in intravenous (IV) and subcutaneous (SC) formulations
Announcement
Takeda announced that the U.S. Food and Drug Administration (FDA) has approved ENTYVIO® (vedolizumab) subcutaneous (SC) administration for maintenance therapy in adults with moderately to severely active Crohn's disease (CD) after induction therapy with intravenous (IV) ENTYVIO.1
AI Summary
Takeda announced that the U.S. Food and Drug Administration (FDA) has approved the subcutaneous (SC) administration of ENTYVIO® (vedolizumab) for maintenance therapy in adults with moderately to severely active Crohn’s disease after induction treatment with intravenous (IV) ENTYVIO. This new approval adds to the existing IV treatment option and allows patients to use a single‐dose prefilled pen called the ENTYVIO Pen, giving them the flexibility to manage their treatment at home.
The decision was based on results from the VISIBLE 2 study, a Phase 3 clinical trial that showed nearly half of the patients maintained long-term clinical remission with the SC formulation. With this development, Takeda aims to provide more convenient treatment options, helping patients achieve remission and improve their overall quality of life.
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