Comprehensive medication guide to Sonidegib including estimated pricing, availability information, side effects, and how to find it in stock at your local pharmacy.
Estimated Insurance Pricing
Commercially insured patients using the Sun Pharma co-pay card pay as little as $10/month. Without the co-pay card, tier 5 specialty tier cost-sharing can be significant. Medicare places Odomzo on Tier 5 of most Part D formularies; prior authorization is required by virtually all plans.
Estimated Cash Pricing
Approximately $14,800 for a 30-day supply of Odomzo 200 mg (brand only; no generic available). With the Sun Pharma co-pay card, commercially insured patients can pay as little as $10 per month.
Medfinder Findability Score
45/100
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Sonidegib, sold under the brand name Odomzo, is an oral targeted cancer therapy classified as a Hedgehog pathway inhibitor. It was FDA-approved on July 24, 2015, for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC). The drug is manufactured and marketed in the United States by Sun Pharmaceutical Industries, Inc.
Sonidegib is indicated specifically for adults with laBCC that has recurred following surgery or radiation therapy, or those who are not candidates for curative surgery or radiation. It comes as a 200 mg oral capsule taken once daily on an empty stomach and is available only through specialty pharmacies.
As of 2026, no generic version of Sonidegib is available in the United States. The drug is distributed exclusively through Sun Pharma's OdomzoCARE specialty pharmacy network and carries a boxed warning for embryo-fetal toxicity.
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Sonidegib is a Smoothened (SMO) antagonist that works by blocking a protein called Smoothened, which is a key switch in the Hedgehog (Hh) signaling pathway. In healthy adults, the Hh pathway is largely inactive, but in nearly all basal cell carcinomas it is abnormally activated—usually due to a mutation in the PTCH1 gene—causing uncontrolled tumor growth.
By binding to and blocking SMO, Sonidegib prevents the Hh pathway from relaying growth signals to cancer cells. Without these signals, BCC tumor cells stop dividing and the tumor may shrink. In the BOLT Phase II clinical trial, Sonidegib 200 mg daily achieved an objective response rate of 56.1% in locally advanced BCC patients at 38.2 months median follow-up.
The drug's musculoskeletal side effects (muscle spasms, elevated CK, rhabdomyolysis) occur because the Hh pathway also plays a role in adult muscle maintenance. Its embryo-fetal toxicity reflects the pathway's critical role in fetal development.
200 mg — capsule
Oral capsule taken once daily on an empty stomach (at least 1 hour before or 2 hours after a meal). The only FDA-approved dose.
Sonidegib is a specialty-only drug not available at retail pharmacies. It is distributed exclusively through Sun Pharma's OdomzoCARE specialty pharmacy network. While Sonidegib is not on the FDA's official drug shortage list as of 2026, the restricted distribution model creates significant access challenges for patients who are unfamiliar with specialty pharmacy workflows.
The primary barriers to access are: specialty-only dispensing (prescription must go to an OdomzoCARE pharmacy), mandatory prior authorization from virtually all insurance plans, and a high cash price of ~$14,800/month with no generic available. Most patients also face delays of several days to weeks before receiving their first dose.
Patients who are struggling to navigate the specialty pharmacy system can use medfinder to identify which pharmacies can fill their specific prescription—saving time and reducing frustration during an already stressful time.
Sonidegib is not a controlled substance and does not require DEA registration to prescribe. However, because it is a specialty oncology drug with serious safety considerations and complex insurance requirements, it is prescribed almost exclusively by specialists with experience in advanced skin cancer management. Most insurance plans require a specialist prescriber for prior authorization approval.
The following provider types commonly prescribe Sonidegib:
Dermatologists (especially those specializing in skin cancer or oncologic dermatology)
Dermatologic oncologists
Mohs surgeons (fellowship-trained, managing complex BCC cases)
Medical oncologists with cutaneous malignancy expertise
Nurse practitioners and physician assistants within oncology or dermatology practices
Telehealth prescribing is not standard for Sonidegib. Initial diagnosis requires in-person biopsy, and baseline laboratory tests (CK, creatinine) must be drawn before starting therapy. Some established patients may have monitoring follow-up appointments via telehealth, but treatment initiation requires in-person evaluation.
No. Sonidegib (Odomzo) is not a controlled substance and is not scheduled under the DEA's Controlled Substances Act. Patients do not need a DEA-controlled prescription, and there are no refill restrictions based on schedule. However, Sonidegib is available by prescription only and must be dispensed through Sun Pharma's authorized OdomzoCARE specialty pharmacy network due to its complex safety profile and restricted distribution requirements.
While not a controlled substance, Sonidegib does carry a boxed warning for embryo-fetal toxicity, and its high risk profile (including rhabdomyolysis risk and complex drug interactions) means it requires close prescriber oversight and is not freely dispensed outside of the specialty pharmacy channel.
The following side effects were reported in 10% or more of patients in the BOLT clinical trial:
Muscle spasms and pain (most common side effect)
Alopecia (hair loss)
Dysgeusia (taste changes)
Fatigue and weakness
Nausea and vomiting
Decreased appetite and weight loss
Diarrhea
Abdominal pain and headache
Pruritus (itching)
Amenorrhea (absence of menstrual periods) in women
Embryo-fetal toxicity (BOXED WARNING): Can cause fetal death or severe birth defects; requires contraception for 20 months after last dose (females) and condoms for 8 months (males)
Rhabdomyolysis: Severe muscle breakdown that can cause kidney failure; monitor CK and renal function; call doctor immediately for dark urine, severe muscle pain/weakness
Elevated creatine kinase (CK): Requires lab monitoring with dose modification per label algorithm
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Vismodegib (Erivedge)
First-in-class SMO inhibitor for BCC, approved 2012. Similar mechanism and efficacy; 150 mg oral capsule once daily. Distributed through Genentech's specialty network. Lacks rhabdomyolysis warnings present in Sonidegib's label.
Cemiplimab (Libtayo)
PD-1 checkpoint inhibitor (immunotherapy) approved for laBCC after hedgehog inhibitor failure or intolerance. Given as IV infusion every 3 weeks. Different mechanism than sonidegib.
Surgery / Mohs Surgery
Gold standard for BCC. Sonidegib is indicated for patients not eligible for surgery; however, if surgical eligibility changes (e.g., tumor shrinkage), surgery remains the preferred option.
Radiation Therapy
Effective for localized BCC. Sonidegib is indicated for patients where radiation has failed or is not feasible; radiation may be considered if circumstances change.
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Strong CYP3A Inhibitors (ketoconazole, itraconazole, ritonavir, amiodarone)
majorIncreases sonidegib blood levels ~2.2-fold; significantly increases risk of musculoskeletal toxicity and rhabdomyolysis. Avoid coadministration.
Strong CYP3A Inducers (carbamazepine, rifampin, phenytoin, St. John's Wort)
majorDecreases sonidegib plasma concentrations, potentially reducing efficacy against cancer. Avoid coadministration.
Statins (atorvastatin, simvastatin, rosuvastatin)
moderateOverlapping muscle toxicity — combination increases risk of elevated CK and rhabdomyolysis. Use with caution; monitor CK closely.
Hydroxychloroquine / Chloroquine
moderateOverlapping muscle toxicity risk. Monitor closely if concurrent use is required.
Fibric acid derivatives (gemfibrozil, fenofibrate)
moderateIncreased risk of muscle-related adverse events with concurrent use. Monitor closely.
Sonidegib (Odomzo) is an effective and FDA-approved treatment for a challenging cancer — locally advanced basal cell carcinoma that has failed or is ineligible for surgery and radiation. With a 56.1% objective response rate in clinical trials, it offers real hope for patients with limited options. However, accessing this medication requires navigating a specialty pharmacy network, prior authorization, and significant financial considerations.
The key challenges with Sonidegib in 2026 are access (specialty-only distribution through OdomzoCARE), cost (approximately $14,800/month cash), and side effects (muscle toxicity and embryo-fetal risk). Financial assistance programs from Sun Pharma and independent foundations can make the drug affordable for most patients, but proactive enrollment and close prescriber monitoring are essential.
If you have been prescribed Sonidegib and are struggling to find or access it, medfinder can call pharmacies on your behalf to identify which ones can fill your prescription. Enter your medication, dosage, and ZIP code and receive your results by text.
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