Endocrinology
Cushing syndrome (endogenous hypercortisolemia): 2 drugs compared for prescribers
Isturisa, Recorlev side by side on what each first fill waits on, what the label requires you to monitor and what an insurer asks to see, with FDA decisions, label changes and open trials for Cushing syndrome (endogenous hypercortisolemia). 2 other FDA-approved medicines for Cushing disease have no prescribing guide here yet and are listed below.
When to suspect Cushing syndrome (endogenous hypercortisolemia) and what to test →The 2 Cushing syndrome (endogenous hypercortisolemia) prescribing guides
One page per drug with the dispensing gate, prior authorization documentation, dosing, monitoring and interactions, each line sourced.
The 2 drugs with a prescribing guide, side by side
Each cell is a summary of that drug's prescribing guide, which carries the full detail and a source on every line. Insurer thresholds are one public policy shown as an example; plans differ.
| Isturisaosilodrostat | Recorlevlevoketoconazole | |
|---|---|---|
| Label dated | November 18, 2025 | March 10, 2026 |
| Starting dose | 2mg orally twice daily, with or without food. | 150mg orally twice daily, with or without food. |
| Dispensing gate | No REMS; baseline ECG, correction of hypokalemia and hypomagnesemia, a CYP3A4 and QT medication review, prior authorization, and a Patient Prescription Form sent to Anovo | No REMS; baseline ALT, AST and total bilirubin, baseline ECG with QTcF 470 msec or less, correction of hypokalemia and hypomagnesemia, a CYP3A4 and QT medication review, prior authorization and dispensing only through PANTHERx Rare Pharmacy |
| Required monitoring | ECG at baseline and within 1 week, then as indicated; two 24-hour UFC collections every 1 to 2 weeks during titration, then cortisol at least every 1 to 2 months; potassium and magnesium periodically; hypocortisolism signs at any time | LFTs weekly for at least 6 weeks, every 2 weeks for 6 weeks, monthly for 3 months; ECG before each dose increase; K and Mg periodically; 24-hour UFC every 2 to 3 weeks during titration, then every 1 to 2 months |
| Example PA threshold | Cigna example: age 18 or older, documented endogenous Cushing syndrome, surgery not an option or not curative or awaiting surgery or radiotherapy response, endocrinologist, preferred product step unless already on Isturisa | Cigna example: age 18 or older, hypercortisolemia, surgery not an option or not curative (or awaiting surgery or radiotherapy effect), ketoconazole tablets tried, endocrinologist or Cushing's specialist |
| Support line | Recordati Rare Diseases R.A.R.E. Patient Support 1-888-855-7273 (1-888-855-RARE), prescriptions filled by Anovo (fax 1-855-917-3510, NCPDP 4445640), $20 co-pay for qualified commercially insured patients | Xeris CareConnection and PANTHERx Rare Pharmacy 1-844-444-RCLV (7258), Start Form fax 1-312-276-4846, CloudTop PA fax 1-872-201-1062; $0 co-pay program for eligible commercial patients |
- Label dated
- November 18, 2025
- Starting dose
- 2mg orally twice daily, with or without food.
- Dispensing gate
- No REMS; baseline ECG, correction of hypokalemia and hypomagnesemia, a CYP3A4 and QT medication review, prior authorization, and a Patient Prescription Form sent to Anovo
- Required monitoring
- ECG at baseline and within 1 week, then as indicated; two 24-hour UFC collections every 1 to 2 weeks during titration, then cortisol at least every 1 to 2 months; potassium and magnesium periodically; hypocortisolism signs at any time
- Example PA threshold
- Cigna example: age 18 or older, documented endogenous Cushing syndrome, surgery not an option or not curative or awaiting surgery or radiotherapy response, endocrinologist, preferred product step unless already on Isturisa
- Support line
- Recordati Rare Diseases R.A.R.E. Patient Support 1-888-855-7273 (1-888-855-RARE), prescriptions filled by Anovo (fax 1-855-917-3510, NCPDP 4445640), $20 co-pay for qualified commercially insured patients
- Label dated
- March 10, 2026
- Starting dose
- 150mg orally twice daily, with or without food.
- Dispensing gate
- No REMS; baseline ALT, AST and total bilirubin, baseline ECG with QTcF 470 msec or less, correction of hypokalemia and hypomagnesemia, a CYP3A4 and QT medication review, prior authorization and dispensing only through PANTHERx Rare Pharmacy
- Required monitoring
- LFTs weekly for at least 6 weeks, every 2 weeks for 6 weeks, monthly for 3 months; ECG before each dose increase; K and Mg periodically; 24-hour UFC every 2 to 3 weeks during titration, then every 1 to 2 months
- Example PA threshold
- Cigna example: age 18 or older, hypercortisolemia, surgery not an option or not curative (or awaiting surgery or radiotherapy effect), ketoconazole tablets tried, endocrinologist or Cushing's specialist
- Support line
- Xeris CareConnection and PANTHERx Rare Pharmacy 1-844-444-RCLV (7258), Start Form fax 1-312-276-4846, CloudTop PA fax 1-872-201-1062; $0 co-pay program for eligible commercial patients
Other FDA-approved medicines for Cushing disease
These have no Trial Friend prescribing guide yet, so they are not in the comparison above. Some are approved for a different form or use of the condition than the guides above, and each drug page gives its indication. The list comes from Trial Friend's audited list of FDA labels that name this condition, built October 21, 2026.
FDA decisions for Cushing syndrome (endogenous hypercortisolemia)
From the Trial Friend FDA decision calendar, which records each date from the sponsor's or the FDA's own announcement.
No pending or recent decisions on the calendar.
Recent label changes
What changed in each label revision, from the FDA's approval letters and the labels' own revision lists.
- November 2025Isturisa. The carton changed to 6 blister packs of 10 tablets, still 60 tablets in all. The FDA approved removing a wallet and sleeve that held the older blister cards of 20. FDA letter
- July 2025Isturisa. Results of a second trial, with a 12-week placebo period, were added. The label also added reports of low white cells with fever and infection. The Patient Information now says to report any one low cortisol symptom, not more than one. FDA letter
- April 2025Isturisa. The FDA broadened the use from Cushing disease to endogenous Cushing syndrome when surgery is not an option or has not been curative. This label version lists only the 1mg and 5mg tablets, without the 10mg. FDA letter
- August 2023Recorlev. The FDA approved a label update after a May 2023 safety letter about lurasidone, an antipsychotic. Lurasidone joined the list of drugs that are contraindicated or not recommended with Recorlev. The distributor address on the label was also updated at that time. FDA letter
- December 2021Recorlev. Recorlev was first approved for high cortisol in adults with Cushing's syndrome when surgery is not an option or was not curative. The FDA asked the company to report all liver injury cases quickly for 5 years. FDA letter
- March 2020Isturisa. Isturisa was first approved for adults with Cushing disease when pituitary surgery was not an option or not curative. The first approval letter covered 1mg, 5mg and 10mg tablets. FDA letter
Open trials
Questions prescribers ask about Cushing syndrome (endogenous hypercortisolemia)
Which Cushing syndrome (endogenous hypercortisolemia) drugs require a REMS?
This answer covers Isturisa and Recorlev, the drugs with a prescribing guide here, and not the 2 other approved medicines listed on this page. None of the 2 Cushing syndrome (endogenous hypercortisolemia) drugs on this page has a REMS: Isturisa and Recorlev. Each prescribing guide lists what does gate the first fill.
What monitoring do Cushing syndrome (endogenous hypercortisolemia) drugs require?
This answer covers Isturisa and Recorlev, the drugs with a prescribing guide here, and not the 2 other approved medicines listed on this page. Isturisa: ECG at baseline and within 1 week, then as indicated; two 24-hour UFC collections every 1 to 2 weeks during titration, then cortisol at least every 1 to 2 months; potassium and magnesium periodically; hypocortisolism signs at any time. Recorlev: LFTs weekly for at least 6 weeks, every 2 weeks for 6 weeks, monthly for 3 months; ECG before each dose increase; K and Mg periodically; 24-hour UFC every 2 to 3 weeks during titration, then every 1 to 2 months.
What do insurers require before covering Isturisa and Recorlev?
Each answer below is one public insurer policy, an example rather than every plan. Isturisa: Cigna example: age 18 or older, documented endogenous Cushing syndrome, surgery not an option or not curative or awaiting surgery or radiotherapy response, endocrinologist, preferred product step unless already on Isturisa. Recorlev: Cigna example: age 18 or older, hypercortisolemia, surgery not an option or not curative (or awaiting surgery or radiotherapy effect), ketoconazole tablets tried, endocrinologist or Cushing's specialist.
Which support programs start Cushing syndrome (endogenous hypercortisolemia) patients on therapy?
This answer covers Isturisa and Recorlev, the drugs with a prescribing guide here, and not the 2 other approved medicines listed on this page. Isturisa: Recordati Rare Diseases R.A.R.E. Patient Support 1-888-855-7273 (1-888-855-RARE), prescriptions filled by Anovo (fax 1-855-917-3510, NCPDP 4445640), $20 co-pay for qualified commercially insured patients. Recorlev: Xeris CareConnection and PANTHERx Rare Pharmacy 1-844-444-RCLV (7258), Start Form fax 1-312-276-4846, CloudTop PA fax 1-872-201-1062; $0 co-pay program for eligible commercial patients.
A reference for licensed professionals, checked on November 10, 2026. Labels and plan policies change; the label on DailyMed and the plan's current policy govern. Not medical advice. For patients: the Cushing syndrome (endogenous hypercortisolemia) page and the first 90 days pages for Isturisa, Recorlev.