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Updated: January 25, 2026

What Is Sonidegib? Uses, Dosage, and What You Need to Know in 2026

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Peter Daggett

Peter Daggett

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Overview

Sonidegib (Odomzo) is an oral cancer drug approved for locally advanced basal cell carcinoma. Here's everything you need to know: uses, dosage, cost, and more for 2026.

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Sonidegib is an oral cancer medication best known by its brand name Odomzo. It is used to treat a specific and challenging form of skin cancer—locally advanced basal cell carcinoma (laBCC)—when surgery or radiation is no longer an option or has failed. Here is a complete, plain-language overview of what Sonidegib is, how it works, how it's taken, and what patients need to know in 2026.

What Is Sonidegib (Odomzo)?

Sonidegib is the generic name; Odomzo is the brand name. It belongs to a class of drugs called Hedgehog pathway inhibitors, specifically Smoothened (SMO) antagonists. It was FDA-approved on July 24, 2015, and is manufactured and marketed in the United States by Sun Pharmaceutical Industries, Inc.

Sonidegib is not a chemotherapy drug in the traditional sense. It is a targeted therapy—it specifically blocks a molecular pathway (the Hedgehog or Hh pathway) that drives growth of certain cancers, including BCC.

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What Is Sonidegib Used For?

Sonidegib is FDA-indicated for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC) in two situations:

laBCC that has recurred following surgery or radiation therapy, OR

laBCC in patients who are not candidates for curative surgery or radiation therapy (due to tumor location, extent, or other medical reasons)

Basal cell carcinoma is the most common form of cancer in the United States. Most BCCs are treated successfully with surgery or localized procedures. Locally advanced BCC is a smaller subset—cases where the cancer is too large, in a difficult location, or has spread locally, making surgery or radiation impractical or impossible.

Sonidegib is also being studied for other cancers with Hh pathway involvement, including medulloblastoma and certain other solid tumors, but these are not FDA-approved uses as of 2026.

How Is Sonidegib Taken?

Sonidegib comes as a 200 mg oral capsule (pink-colored, opaque) and is taken once daily. Important dosing instructions:

Take on an empty stomach: At least 1 hour before or 2 hours after a meal.

Take at the same time each day: Consistency helps maintain stable blood levels.

If you miss a dose: Skip the missed dose and take the next scheduled dose. Do not double up.

Do not modify the dose without instruction: The approved dose is 200 mg/day. Changes are only made by your doctor based on side effects or lab results.

Store at room temperature: 77°F (25°C), with excursions permitted to 59-86°F. Keep away from light and moisture.

Is Sonidegib a Controlled Substance?

No. Sonidegib (Odomzo) is not a controlled substance. It is not scheduled under the DEA's Controlled Substances Act. However, it is available by prescription only and must be dispensed through authorized specialty pharmacies due to its safety profile and restricted distribution model.

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How Effective Is Sonidegib?

The FDA approval of Sonidegib is based on the Phase II BOLT trial (NCT01327053). At a median follow-up of 38.2 months, the objective response rate (ORR) was 56.1% in patients with locally advanced BCC receiving Sonidegib 200 mg daily. This means more than half of patients had measurable tumor shrinkage. This is considered a strong result for a cancer population that had previously failed surgery and/or radiation.

How Much Does Sonidegib Cost?

Sonidegib is an expensive specialty medication. The cash price for a 30-day supply is approximately $14,800. There is no generic version as of 2026. However, significant financial assistance is available:

Commercially insured patients may pay as little as $10/month with the Sun Pharma co-pay card.

Uninsured or underinsured patients may qualify for the Sun Pharma Patient Assistance Program and receive it at no cost.

Medicare patients may access assistance through disease-specific foundations.

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Key Things to Know Before Starting Sonidegib

Boxed warning for embryo-fetal toxicity — must use contraception during and for 20 months after treatment (females), 8 months (males)

Requires baseline labs: serum CK and renal function before starting

Muscle spasms and pain are very common — know the warning signs of rhabdomyolysis

Available only through specialty pharmacies — cannot be filled at retail locations

Prior authorization required by virtually all insurance plans

Finding Sonidegib When You Need It

Because Sonidegib is only available at specialty pharmacies, many patients struggle to get their prescription filled. medfinder is a service that calls pharmacies on your behalf to identify which ones can fill your prescription—you just provide your medication, dosage, and ZIP code and receive results by text. See also our guide on how to find Sonidegib in stock.

Frequently Asked Questions

Sonidegib (brand name Odomzo) is FDA-approved for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation, or in patients who are not candidates for surgery or radiation therapy. It is not used for early-stage or superficial BCC, which is typically treated with surgery or topical agents.

Sonidegib is classified as an antineoplastic (anti-cancer) agent, but it is a targeted therapy rather than traditional chemotherapy. It specifically blocks the Hedgehog signaling pathway—a molecular pathway that drives BCC growth—rather than broadly killing dividing cells the way chemotherapy does.

Sonidegib is taken as a 200 mg oral capsule once daily, on an empty stomach (at least 1 hour before or 2 hours after a meal). It should be taken at the same time each day. If a dose is missed, skip it and resume the next scheduled dose — do not double up.

No. As of 2026, there is no FDA-approved generic version of Sonidegib. Odomzo remains a brand-only specialty drug, which contributes to its high cash price of approximately $14,800 per month. Financial assistance programs from Sun Pharma and nonprofit foundations can help make it more affordable.

In the Phase II BOLT trial, Sonidegib 200 mg daily achieved an objective response rate of 56.1% in patients with locally advanced BCC at a median follow-up of 38.2 months. This means more than half of patients had measurable tumor shrinkage, which is considered a strong result for this patient population.

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