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InnoPharmax

InnoPharmax works on 1 rare disease tracked on Trial Friend, including Cholangiocarcinoma, with 2 recruiting clinical trials.

InnoPharmax is a Taipei, Taiwan-based pharmaceutical company working on a deceptively practical idea: taking chemotherapy drugs that have only ever existed as hospital IV infusions and turning them into capsules a patient can swallow at home. Its lead program, D07001, is an oral softgel formulation of gemcitabine, a chemotherapy backbone that has been given intravenously for roughly 3 decades.

D07001 is more than a convenience play. The capsule uses metronomic dosing, meaning low doses taken frequently rather than the large periodic infusions of traditional chemotherapy. That schedule is designed to keep killing tumor cells while also modulating the immune response and cutting off the blood vessel growth tumors depend on, with less of the systemic toxicity that makes conventional gemcitabine hard to tolerate. For bile duct cancer (cholangiocarcinoma), an aggressive rare cancer where patients often carry a double burden of disease symptoms and chemotherapy side effects, an oral low-toxicity option would represent a genuine shift in how treatment feels day to day.

The company's pivotal Phase 3 study of D07001 (NCT06622057) began in June 2026, with sites in the United States and Taiwan. It is a double-blind, randomized trial in about 240 adults with advanced biliary tract cancer, including bile duct cancer, after gemcitabine plus cisplatin and then FOLFOX or irinotecan chemotherapy stopped working or caused side effects they could not tolerate, or who declined FOLFOX. Everyone takes capecitabine pills, and each person also gets 1 of 2 D07001 doses or a placebo; the main goal is longer survival. A separate open-label Phase 2/3 study in Taiwan is testing D07001 with capecitabine or TS-1, and Phase 1 results in advanced solid tumors were published in The Oncologist in 2025. The company has also said it plans to pursue a Phase 3 program in pancreatic cancer.

Like many mid-sized Taiwanese pharma companies, InnoPharmax funds its research partly through a specialty and generics business: it won approval for a generic version of sapropterin (the phenylketonuria treatment better known as Kuvan) and, with partner Shandong New Era Pharmaceutical, brought a gadopentetate imaging agent through China's NMPA. A late-2024 capital raise of NT$225 million was earmarked specifically to push D07001 through the clinic under CEO Wei-Hua Hao.

Type
Rare Disease Specialist
Headquarters
Taipei, Taiwan
2
Active Rare Disease Trials
1
Rare Diseases in Portfolio

InnoPharmax Drug Pipeline

InnoPharmax has 2 active clinical trials across 1 development stage, with 2 currently recruiting participants. Clinical trials advance through phases: Phase 1 tests safety in a small group, Phase 2 evaluates effectiveness and side effects, Phase 3 confirms benefit in a larger population, and Phase 4 monitors long-term safety after FDA approval.

Note: This pipeline counts the active and recruiting trials listed on this page, from ClinicalTrials.gov. For companies that work outside rare disease, we list only trials for rare diseases we track, so the company's full pipeline may be larger.

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2
Phase 32 trials
Biliary Tract Cancer (BTC)
Recruiting
Biliary Tract Cancer
Recruiting

InnoPharmax Clinical Trials (2)

Active and recruiting clinical trials sponsored by InnoPharmax, sourced live from ClinicalTrials.gov. Each trial card shows the study phase, current recruitment status, conditions under investigation, study locations, eligibility criteria, and a direct link to the full ClinicalTrials.gov record. You can also download a one-page PDF summary to share with your doctor.

Note: Recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator.

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RECRUITINGPHASE3Recently updatedNCT06622057

D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer

Intervention: D07001-Softgel Capsules, Placebo, Capecitabine

Biliary Tract Cancer (BTC)

The object of this trial is to evaluate the efficacy of D07001-softgel capsules + capecitabine compared with placebo + capecitabine by overall survival (OS). Eligible patients with advanced biliary tract cancer (BTC) will be randomized (1:1:1) to receive either 60 mg D07001-softgel, 100 mg D07001-softgel, or placebo, combine with capecitabine. Treatment will be continued until disease progression, death, withdraw consent, or completing 12 treatment cycles , whichever occurs first.

Ages 18 Years+4 locations
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RECRUITINGPHASE2, PHASE3Hasn't posted an update in over a yearNCT05065957

Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer

Intervention: D07001-softgel capsules + Xeloda (or TS-1), mFOLFOX

Biliary Tract Cancer

The primary objective are: To assess the safety and tolerability of the combination of D07001-softgel capsules and Xeloda/TS-1. To evaluate the efficacy of the combination of D07001-softgel capsules and Xeloda/TS-1, as assessed by disease control rate (DCR).

Ages 18 Years+5 locations
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FDA-Approved Drugs

No FDA-approved drugs found for this company at this time.

InnoPharmax Trial Locations

InnoPharmax clinical trials are running at 9 sites in 2 countries. Click any country to drill down by state, city, and individual research facility. Proximity to a trial site is one of the most important factors in deciding whether to participate.

Taiwan
6▼
United States
3▼

Rare Disease Focus Areas (1)

Diseases targeted by InnoPharmax's clinical trial and drug development programs

Patient Resources

Organizations and resources related to InnoPharmax's rare disease focus areas

Frequently Asked Questions About InnoPharmax

Common questions about InnoPharmax's rare disease programs, clinical trials, and treatments.